Ilgaz Aydinlar Elif, Erdogan Soyukibar Tuba, Yalinay Dikmen Pinar
Department of Neurology, Acıbadem University School of Medicine, Istanbul, Türkiye.
Front Neurol. 2024 Jun 19;15:1417303. doi: 10.3389/fneur.2024.1417303. eCollection 2024.
OBJECTIVE: This real-world study aimed to investigate how onabotulinumtoxinA affects the outcome of migraine, along with accompanying anxiety, depression, and bruxism among a group of patients with chronic migraine (CM) and define predictors of good response. METHODS: Patients diagnosed with CM who received onabotulinumtoxinA were included in this single-center, real-world retrospective cohort study. Monthly headache days (MHDs), monthly migraine days (MMDs), headache intensity (numeric rating scale-NRS) and headache characteristics were evaluated at baseline and 12 weeks post-treatment. Patient-reported outcome measures (PROMs) included Migraine Disability Assessment Scale (MIDAS), Headache Impact Test-6 (HIT-6) scores, 12-item Allodynia Symptom Checklist (ASC-12), Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI). Response to onabotulinumtoxinA (% reduction in MHDs) and treatment-related adverse events (TRAEs) were also evaluated. OnabotulinumA was applied to the masseter muscles in patients complaining of bruxism. RESULTS: A total of 72 patients (mean ± SD age: 36.3 ± 8.5 years; 91.7% were female) diagnosed with CM were included. OnabotulinumtoxinA revealed significant decrease in median (IQR) MHDs [from 20(15-25) at baseline to 6(4-10), < 0.001], MMDs [from 9(6-12) to 3(1-6), < 0.001] and NRS [from 9(8-10) to 7(6-8), < 0.001], and the MIDAS [from 54(30-81) to 16(7-24), < 0.001], HIT-6 [from 67(65-69) to 58(54-64), < 0.001], ASC-12 [from 6(1.5-9) to 2(0-9), = 0.002], BAI [from 12(6.5-19) to 9(3-17), < 0.001] and BDI [from 11(6.5-17) to 3(2-7) < 0.001] scores at 12 weeks post-treatment. Patients complaining of bruxism received onabotulinumtoxinA injections in the first = 27 (37.5%) and 12. week post-treatment = 19 (70.4%) periods. Overall, 70.8% of patients responded (≥50% reduction in MHDs), while 29.2% did not (<50% reduction). Both groups showed similar characteristics in demographics, migraine history, baseline PROMs scores, comorbidities, and prior treatments. CONCLUSION: OnabotulinumtoxinA is an effective treatment option that rapidly improves migraine outcomes, disability, and impact while also alleviating comorbid depression and/or anxiety. This study's noteworthy finding is that onabotulinumtoxinA is effective in a majority of CM patients, irrespective of their prior treatment history, migraine characteristics, or concurrent comorbidities. Furthermore, we identified no specific predictors for a favorable response to onabotulinumtoxinA. Applying onabotulinumtoxinA to the masseter muscles can relieve discomfort associated with concurrent bruxism; however, it does not impact migraine outcomes.
目的：这项真实世界研究旨在调查A型肉毒毒素对一组慢性偏头痛（CM）患者偏头痛结局以及伴随的焦虑、抑郁和磨牙症的影响，并确定良好反应的预测因素。 方法：本单中心、真实世界回顾性队列研究纳入了诊断为CM且接受A型肉毒毒素治疗的患者。在基线和治疗后12周评估每月头痛天数（MHDs）、每月偏头痛天数（MMDs）、头痛强度（数字评定量表-NRS）和头痛特征。患者报告的结局指标（PROMs）包括偏头痛残疾评估量表（MIDAS）、头痛影响测试-6（HIT-6）评分、12项异常性疼痛症状清单（ASC-12）、贝克焦虑量表（BAI）和贝克抑郁量表（BDI）。还评估了对A型肉毒毒素的反应（MHDs减少百分比）和治疗相关不良事件（TRAEs）。对主诉有磨牙症的患者，将A型肉毒毒素注射到咬肌中。 结果：共纳入72例诊断为CM的患者（平均±标准差年龄：36.3±8.5岁；91.7%为女性）。A型肉毒毒素治疗后12周时，中位数（IQR）MHDs[从基线时的20（15-25）降至6（4-10），P<0.001]、MMDs[从9（6-12）降至3（1-6），P<0.001]和NRS[从9（8-10）降至7（6-8），P<0.001]，以及MIDAS[从54（30-81）降至16（7-24），P<0.001]、HIT-6[从67（65-69）降至58（54-64），P<0.001]、ASC-12[从6（1.5-9）降至2（0-9），P=0.002]、BAI[从12（6.5-19）降至9（3-17），P<0.001]和BDI[从11（6.5-17）降至3（2-7），P<0.001]评分均显著降低。主诉有磨牙症的患者在治疗的第1个月有27例（37.5%）接受了A型肉毒毒素注射，治疗后12周有19例（70.4%）接受了注射。总体而言，70.8%的患者有反应（MHDs减少≥50%），而29.2%的患者无反应（MHDs减少<50%）。两组在人口统计学、偏头痛病史、基线PROMs评分、合并症和既往治疗方面表现出相似的特征。 结论：A型肉毒毒素是一种有效的治疗选择，可迅速改善偏头痛结局、残疾状况和影响，同时还可缓解合并的抑郁和/或焦虑。本研究的显著发现是，A型肉毒毒素对大多数CM患者有效，无论其既往治疗史、偏头痛特征或并发合并症如何。此外，我们未发现对A型肉毒毒素良好反应的特定预测因素。将A型肉毒毒素注射到咬肌中可缓解与并发磨牙症相关的不适；然而，它不影响偏头痛结局。
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