The safety and efficacy of onabotulinumtoxinA injections for children and adolescents with chronic migraine: A systematic review and meta-analysis.

IF 5.4 2区 医学 Q1 CLINICAL NEUROLOGY Headache Pub Date : 2024-11-01 Epub Date: 2024-08-11 DOI:10.1111/head.14798
Rebecca Lindsay, Amira Kalifa, Jonathan Kuziek, Marielle Kabbouche, Andrew D Hershey, Serena L Orr
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Abstract

Objective: To qualitatively and quantitatively summarize the evidence for the use of onabotulinumtoxinA injections in children and adolescents with migraine.

Background: There are limited evidence-based treatment options for youth with migraine, especially youth with chronic migraine (CM). OnabotulinumtoxinA injections are an established evidence-based treatment for adults with CM. While several studies have assessed their safety and efficacy among adolescents with CM, there are no published systematic reviews summarizing the pediatric evidence.

Methods: We carried out a systematic review, reported according to the Preferred Reporting Items for Systematic Review and Meta-Analysis, aiming to identify studies that included five or more children and adolescents aged ≤18 years with a diagnosis of migraine, who were treated with ≥50 units (U) of onabotulinumtoxinA and had outcomes assessed ≥4 weeks after one or more injection cycle. Both observational studies and randomized controlled trials (RCTs) were eligible for inclusion. Two investigators independently carried out the first (titles and abstracts) and second (full text) screening stages, as well as data extraction and quality appraisal. The American Academy of Neurology risk of bias grading scheme was used to assess study risk of bias. Studies with adequate data were pooled using random effects meta-analyses, and Hedge's g standardized mean differences with 95% confidence intervals (CIs) were generated to estimate the effect sizes of the continuous outcomes included. Studies lacking data required for meta-analysis were summarized qualitatively.

Results: We screened 634 studies and included 14 studies comprising 491 participants, of whom 489 had CM. Two studies were RCTs, 12 were observational uncontrolled studies, and all but one study included only youth with CM. Five Class IV observational uncontrolled studies were amenable to pooling in meta-analyses. After a mean of 2-2.6 injection cycles, headache frequency was shown to decrease significantly after treatment with onabotulinumtoxinA (Hedge's g = 0.97, 95% CI 0.58-1.35; p < 0.0001), as did severity (Hedge's g = 1.24, 95% CI 0.55-1.94; p = 0.0005), with both estimates having a large effect size magnitude. A Class I parallel-group RCT of one injection series (155 U, 74 U, or placebo), powered to detect a change in 4 headache days per month, did not find outcome differences between the active and placebo treatment arms. A Class IV crossover RCT showed superiority of active (155 U) versus placebo injections. The remaining Class IV observational studies that were excluded from the meta-analyses all showed improved outcomes with onabotulinumtoxinA injections over time. No serious adverse events related to treatment occurred.

Conclusion: OnabotulinumtoxinA injections have established safety for use in children and adolescents with CM and are likely effective in reducing headache frequency and severity over time. However, in the absence of an adequately powered parallel-group RCT assessing the efficacy of multiple injection cycles, it remains unclear if this intervention is superior to placebo.

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对患有慢性偏头痛的儿童和青少年注射奥诺布林毒素A的安全性和有效性:系统回顾和荟萃分析。
摘要对儿童和青少年偏头痛患者使用鬼臼毒素A注射剂的证据进行定性和定量总结:背景:针对青少年偏头痛患者,尤其是患有慢性偏头痛(CM)的青少年的循证治疗方案十分有限。注射奥诺博定是治疗成人偏头痛的一种成熟的循证治疗方法。虽然有几项研究对青少年偏头痛患者的安全性和有效性进行了评估,但目前还没有公开发表的系统性综述对儿科证据进行总结:我们根据《系统综述和荟萃分析首选报告项目》进行了一项系统综述,旨在确定纳入五名或五名以上诊断为偏头痛的 18 岁以下儿童和青少年的研究,这些儿童和青少年接受了≥50 单位(U)的阿那曲妥毒素治疗,并在一个或多个注射周期后≥4 周进行了疗效评估。观察性研究和随机对照试验(RCT)均符合纳入条件。两名研究人员分别独立完成了第一阶段(标题和摘要)和第二阶段(全文)的筛选,以及数据提取和质量评估。美国神经病学学会偏倚风险分级方案用于评估研究的偏倚风险。使用随机效应荟萃分析对数据充分的研究进行汇总,并生成带有 95% 置信区间 (CI) 的 Hedge's g 标准化均值差异,以估计纳入的连续性结果的效应大小。对缺乏荟萃分析所需数据的研究进行了定性总结:我们筛选了 634 项研究,纳入了 14 项研究,共有 491 名参与者,其中 489 人患有 CM。其中 2 项研究为研究性对照研究,12 项为观察性非对照研究,除一项研究外,其他所有研究都只纳入了患有 CM 的青少年。其中五项第四类观察性非对照研究适合汇总进行荟萃分析。平均 2-2.6 个注射周期后,头痛频率明显降低(Hedge's g = 0.97,95% CI 0.58-1.35;P 结论:头痛频率明显降低:奥那巴妥珠单抗注射液在儿童和青少年脑卒中患者中的安全性已得到证实,而且随着时间的推移,可能会有效降低头痛的频率和严重程度。然而,由于缺乏一项充分有效的平行组 RCT 研究来评估多个注射周期的疗效,目前仍不清楚这种干预措施是否优于安慰剂。
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来源期刊
Headache
Headache 医学-临床神经学
CiteScore
9.40
自引率
10.00%
发文量
172
审稿时长
3-8 weeks
期刊介绍: Headache publishes original articles on all aspects of head and face pain including communications on clinical and basic research, diagnosis and management, epidemiology, genetics, and pathophysiology of primary and secondary headaches, cranial neuralgias, and pains referred to the head and face. Monthly issues feature case reports, short communications, review articles, letters to the editor, and news items regarding AHS plus medicolegal and socioeconomic aspects of head pain. This is the official journal of the American Headache Society.
期刊最新文献
Headaches in Sjogren's disease: A narrative review. Occipital neuralgia as an initial manifestation of atypical Lemierre syndrome: A case report. Safety and tolerability of ubrogepant for the acute treatment of migraine in participants taking atogepant for the preventive treatment of episodic migraine: Results from the TANDEM study. Anxiety, depression, and headache-related disability in a large pediatric clinic-based sample. Associations of comorbid headache disorders and depression with leisure-time physical activity among 14,088 adults in The Brazilian Longitudinal Study of Adult Health.
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