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Efficacy, Safety, and Acceptability of Pharmacologic Treatments for Pediatric Migraine Prophylaxis
JAMA Pediatrics ( IF 26.1 ) Pub Date : 2020-04-01 , DOI: 10.1001/jamapediatrics.2019.5856
Cosima Locher 1, 2, 3 , Joe Kossowsky 2, 3 , Helen Koechlin 2, 3 , Thanh Lan Lam 4 , Johannes Barthel 4 , Charles B Berde 3 , Jens Gaab 2 , Guido Schwarzer 5 , Klaus Linde 6 , Karin Meissner 4, 7
Affiliation  

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.

中文翻译:

预防小儿偏头痛的药物治疗的有效性、安全性和可接受性

重要性 偏头痛是儿童和青少年最常见的神经系统疾病之一。然而,缺乏对儿科人群中多种预防性药物治疗的定量比较。目的检查预防性药物治疗是否比安慰剂更有效,以及药物之间在疗效、安全性和可接受性方面是否存在差异。数据来源 对 MEDLINE、Cochrane、Embase 和 PsycINFO 中发表至 2018 年 7 月 2 日的研究进行系统评价和网络荟萃分析。研究选择 纳入了对诊断为发作性偏头痛的儿童和青少年进行预防性药物治疗的随机临床试验。摘要、标题和全文筛选由4名审稿人独立进行。数据提取和综合数据提取是根据系统评价和元分析网络元分析指南的首选报告项目进行的。使用 Cochrane 偏倚风险工具评估质量。在随机效应模型中评估效应大小,计算为主要结果的标准化平均差异和停药率的风险比。主要结果和测量主要结果是疗效(即偏头痛频率、偏头痛天数、头痛天数、头痛频率或头痛指数)、安全性(即由于不良事件而停止治疗)和可接受性(即治疗因任何原因停产)。结果 23 项研究(2217 名患者)符合纳入条件。预防性药物治疗包括抗癫痫药、抗抑郁药、钙通道阻滞剂、抗高血压药和食品补充剂。在短期内(<5 个月),普萘洛尔(标准平均差,0.60;95% CI,0.03-1.17)和托吡酯(标准平均差,0.59;95% CI,0.03-1.15)明显比安慰剂更有效。然而,这些药物的 95% 预测区间包含无效效应。相对于安慰剂,没有发现任何干预措施对偏头痛预防的显着长期影响。结论和相关性 预防性药物治疗几乎没有证据支持小儿偏头痛的疗效。未来的研究可以 (1) 确定与个体对药物预防的反应相关的因素,
更新日期:2020-04-01
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