Efficacy and Safety of 400 and 800 mg Etodolac vs. 1,000 mg Paracetamol in Acute Treatment of Migraine: A Randomized, Double‐blind, Crossover, Multicenter, Phase III Clinical Trial
Abstract:Our study showed that etodolac is a safe and effective alternative in acute migraine treatment and showed comparable efficacy to paracetamol 1,000 mg. Etodolac may be considered as an alternative option for acute treatment of migraine.
“…After deleting duplicates and eliminating the papers that did not satisfy the eligibility criteria or presented one or more of the exclusion criteria, only 24 out of the 243 selected papers resulted in being eligible for further evaluation (13–36) (Figure 1, flow diagram). Figure 1.Data collection flow diagram.…”
Background The International Headache Society (IHS) has published four editions of Guidelines for acute clinical trials in migraine in the past 28 years. This continuous update process has been driven by the increasing amount of scientific data in the field of migraine and by the need to continuously improve the quality of trials. Objectives To illustrate: i) the results of the analysis on the adherence of published trials to the 3rd edition published in 2012, in order to identify the critical areas that needed to be addressed in the 4th edition and ii) the changes introduced in this latter edition for improving adherence and methodology robustness. Methods We searched and reviewed all controlled trials on acute treatment of migraine published in the period 2012–2018 and we assessed their adherence to the 3rd edition of the IHS Guidelines using a score system based on the most important recommendations. Afterwards, we compared the two editions of the Guidelines and assessed the changes between them. Results We included data from 24 controlled clinical trials. Most trials had a randomized double-blind controlled (RDB) design, while a minority (16.7%) were non-randomized double-blind trials. Less than half (44.6%) of the RDB trials used the recommended “pain-free at 2 hours” endpoint as the primary efficacy measure. Trial design and evaluation of results were the areas that diverged the most from the recommendations. Conclusion Adherence to IHS guidelines for clinical trials has been suboptimal so far. The new edition has been adapted and optimized to facilitate uptake and strengthen the quality of evidence.
“…After deleting duplicates and eliminating the papers that did not satisfy the eligibility criteria or presented one or more of the exclusion criteria, only 24 out of the 243 selected papers resulted in being eligible for further evaluation (13–36) (Figure 1, flow diagram). Figure 1.Data collection flow diagram.…”
Background The International Headache Society (IHS) has published four editions of Guidelines for acute clinical trials in migraine in the past 28 years. This continuous update process has been driven by the increasing amount of scientific data in the field of migraine and by the need to continuously improve the quality of trials. Objectives To illustrate: i) the results of the analysis on the adherence of published trials to the 3rd edition published in 2012, in order to identify the critical areas that needed to be addressed in the 4th edition and ii) the changes introduced in this latter edition for improving adherence and methodology robustness. Methods We searched and reviewed all controlled trials on acute treatment of migraine published in the period 2012–2018 and we assessed their adherence to the 3rd edition of the IHS Guidelines using a score system based on the most important recommendations. Afterwards, we compared the two editions of the Guidelines and assessed the changes between them. Results We included data from 24 controlled clinical trials. Most trials had a randomized double-blind controlled (RDB) design, while a minority (16.7%) were non-randomized double-blind trials. Less than half (44.6%) of the RDB trials used the recommended “pain-free at 2 hours” endpoint as the primary efficacy measure. Trial design and evaluation of results were the areas that diverged the most from the recommendations. Conclusion Adherence to IHS guidelines for clinical trials has been suboptimal so far. The new edition has been adapted and optimized to facilitate uptake and strengthen the quality of evidence.
“…We identified 51 (8–58) RCTs on acute migraine treatments and 22 (59–79) RCTs on prophylactic migraine treatments. The results are presented in Tables 1–3 (for d...…”
Background In 2008, the International Headache Society published guidelines on the "evaluation and registration of adverse events in clinical drug trials on migraine". They listed seven recommendations for reporting adverse events in randomized controlled trials on migraine. The present study aimed to evaluate adherence to these recommendations, and based on the results, to recommend improvements. Methods We searched the PubMed/MEDLINE database to identify controlled trials on migraine drugs published from 2010 to 2015. For each trial, we noted whether five of the recommended parameters were presented. In addition, we noted whether adverse events were reported in abstracts. Results We identified 73 trials; 51 studied acutely administered drugs and 22 studied prophylactic drugs for migraine. The number of patients with any adverse events were reported in 74% of acute-administration and 86% of prophylactic drug trials. Only 30 (41%) of the 73 studies reported adverse events with data in the abstracts, and 27 (37%) abstracts did not mention adverse events. Conclusion Adverse events, both frequency and symptoms, should be reported to allow a fair judgement of benefit/tolerability ratio when randomized controlled trials in migraine treatment are published. Clinically significant adverse events should be included in the abstract of every randomized controlled trial in migraine treatment.
“…Migrende etkinliği gösterilmiş analjezikler asetil salisilik asit (ASA) (500-1000 mg), ibuprofen (200-800 mg), diklofenak (50-100 mg), etodolak (400-800 mg), parasetamol (1000 mg), metamizol (1000 mg) ve ülkemizde piyasada bulunmayan tofenamik asit (200 mg) ve fenazondur (1000 mg) (16,17,18,19,20,21,22,23,24). Ayrıca, ASA, parasetamol ve kafein kombinasyonlarının bu maddelerin tek başına ya da kafeinsiz kullanımdan daha etkili olduğu gösterilmiştir (25).…”
Migraine is one of the most frequent disabling neurological conditions with a major impact on the patient's quality of life. Migraine has been described as a chronic disorder that characterized with attacks. Attacks are characterized by moderate-severe, often unilateral, pulsating headache attacks, typically lasting 4 to 72 hours. Migraine remains underdiagnosed and undertreated despite advances in the understanding of its pathophysiology. This article reviews management of migraine acute pharmacological treatment. Currently, for the acute treatment of migraine attacks, non-steroidal anti-inflammatory drugs (NSAIDs) and triptans (serotonin 5HT1B/1D receptor agonists) are recommended. Before intake of NSAID and triptans, metoclopramide or domperidone is useful. In very severe attacks, subcutaneous sumatriptan is first choice. The patient should be treated early in the attack, use an adequate dose and formulation of a medication. Ideally, acute therapy should be restricted to no more than 2 to 3 days per week to avoid medication overuse.
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