Impact of preventive pill-based treatment on migraine days: A secondary outcome study of the Childhood and Adolescent Migraine Prevention (CHAMP) trial and a comparison of self-report to nosology-derived assessments.
Impact of preventive pill-based treatment on migraine days: A secondary outcome study of the Childhood and Adolescent Migraine Prevention (CHAMP) trial and a comparison of self-report to nosology-derived assessments.
复制标题
基于预防性药物的治疗对偏头痛日的影响：儿童和青少年偏头痛预防 (CHAMP) 试验的次要结果研究以及自我报告与分类学评估的比较。
作者：
Gibler,RobertC;Peugh,JamesL;Coffey,ChristopherS;Chamberlin,LeighAnn;Ecklund,Dixie;Klingner,Elizabeth;Yankey,Jon;Korbee,LeslieL;Kabbouche,Marielle;Kacperski,Joanne;Porter,LindaL;Reidy,BrookeL;Hershey,AndrewD;Powers,Scott
目的检查在儿童和青少年偏头痛预防（CHAMP）试验结束前完成的青少年自我报告偏头痛天数的组间差异，并探讨自我报告与“疾病分类学衍生”（即，国际头痛疾病分类，第3版[ICHD-3]）偏头痛天数。背景CHAMP试验比较了阿米替林和托吡酯与安慰剂在青年偏头痛预防中的作用，并建议分析偏头痛天数的变化作为次要结果。有相当大的变化，在该领域关于什么构成了“偏头痛日”，这是如何确定和报告的试验，以及如何一致，这些措施与诊断nosology.MethodsCHAMP试验完成者（N= 175）随机接受阿米替林（n= 77），托吡酯（n= 63），或安慰剂（n= 35）。参与者每天保持头痛日记，他们每天报告头痛以及他们是否认为头痛是偏头痛。对于每个头痛日，参与者完成症状记录并报告症状，如疼痛部位和恶心/呕吐或恐惧症和声音恐惧症的存在。我们检查了试验完成时自我报告的偏头痛天数（试验第20-24周的总和）与基线相比的组间差异。我们还使用了一种算法来确定参与者的症状报告是否符合ICHD-3无先兆偏头痛的标准，并检查了自我报告和“疾病分类学衍生”偏头痛days.ResultsResults之间的关联显示，在试验过程中，两组自我报告的偏头痛天数没有显著差异。在基线和治疗阶段自我报告和“疾病分类学衍生”的偏头痛天数密切相关（r =0.73和0.83，分别;p < 0.001）. Conclusion无论治疗如何，CHAMP试验完成者在试验过程中自我报告的偏头痛天数显示出临床重要的减少（约少3.8天）。自我报告和“疾病分类学衍生”偏头痛天数之间的强相关性表明，患有偏头痛的青少年可以识别偏头痛的一天，并可靠地报告他们的头痛特征和症状。在试验中偏头痛天数的计算和报告中需要更严格和更透明。
ObjectiveTo examine group differences in self‐reported migraine days among youth who completed the Childhood and Adolescent Migraine Prevention (CHAMP) trial prior to its closure and explore the relationship between self‐reported and “nosology‐derived” (i.e., International Classification of Headache Disorders, 3rd edition [ICHD‐3]) migraine days.BackgroundThe CHAMP trial compared amitriptyline and topiramate to placebo for migraine prevention in youth and proposed to analyze change in migraine days as a secondary outcome. There is considerable variability in the field regarding what constitutes a “migraine day,” how this is determined and reported in trials, and how consistent these measures are with diagnostic nosology.MethodsCHAMP trial completers (N= 175) were randomized to receive amitriptyline (n= 77), topiramate (n= 63), or placebo (n= 35). Participants maintained daily headache diaries where they reported each day with headache and if they considered that headache to be a migraine. For each headache day, participants completed a symptom record and reported about symptoms such as pain location(s) and presence of nausea/vomiting or photophobia and phonophobia. We examined group differences in self‐reported migraine days at trial completion (summed from trial weeks 20–24) compared to baseline. We also used an algorithm to determine whether participants’ symptom reports met ICHD‐3 criteria for migraine without aura, and examined the association between self‐reported and “nosology‐derived” migraine days.ResultsResults showed no significant differences between groups in self‐reported migraine days over the course of the trial. Self‐reported and “nosology‐derived” migraine days during the baseline and treatment phases were strongly associated (r's=0.73 and 0.83, respectively;p's < 0.001).ConclusionRegardless of treatment, CHAMP trial completers showed clinically important reductions in self‐reported migraine days over the course of the trial (about 3.8 days less). The strong association between self‐reported and “nosology‐derived” migraine days suggests youth with migraine can recognize a day with migraine and reliably report their headache features and symptoms. Greater rigor and transparency in the calculation and reporting of migraine days in trials is needed.