Abstract：
BACKGROUND: Migraine and dizziness often coexist, with vestibular migraine (VM) presenting with vestibular symptoms and headaches. Calcitonin gene-related peptide (CGRP) may be involved in motion-induced symptoms; however, studies on the use of anti-CGRP monoclonal antibodies (mAbs) for the treatment of VM have yielded conflicting results. This study aimed to clarify the effectiveness of anti-CGRP mAbs in VM treatment.
METHODS: This retrospective observational cohort study, conducted between 1 January 2021 and 31 March 2023, assessed 12 Japanese patients with VM who were treated with anti-CGRP mAbs (CGRP group) for 6 months and 11 Japanese patients who received standard of care for VM and served as controls. Clinical questionnaires and equilibrium tests were administered, with primary outcomes including changes in Dizziness Handicap Inventory (DHI) scores compared with baseline values. Objective variables included the DHI score and explanatory variables included demographic data, balance test results, head-up tilt (HUT) test results, vestibular test results and questionnaire survey results. Analysis of variance was used to assess the treatment effects of anti-CGRP mAbs, and multivariate regression analysis was performed to identify mAb responders.
RESULTS: After 6 months, the CGRP group showed significant improvements in DHI scores [0 versus 6 months, odds ratio (95% confidence interval): 22.01 (0.13-43.88)] and number of vertigo/dizziness attacks per month [0 versus 6 months: 10.28 (2.80-17.76)]. No significant difference was observed in the control group [DHI scores, 0 versus 6 months: 0.65 (-26.84 to 28.14); number of vertigo/dizziness attacks per month, 0 versus 6 months: - 8.07 (- 23.77 to 7.62)]. Multivariate regression analysis showed that autonomic function at baseline was associated with mAb response in patients [β estimates (95% confidence interval): 3.63 (0.21-7.06)].
CONCLUSIONS: Treatment with anti-CGRP mAbs was more effective than conventional treatment in preventing migraine in patients with VM. While the identified factors associated with treatment responsiveness offer valuable insights into personalised treatment approaches, further prospective studies are warranted to validate the findings due to our study\'s retrospective design and limited sample size.
METHODS: This retrospective observational cohort study, conducted between 1 January 2021 and 31 March 2023, assessed 12 Japanese patients with VM who were treated with anti-CGRP mAbs (CGRP group) for 6 months and 11 Japanese patients who received standard of care for VM and served as controls. Clinical questionnaires and equilibrium tests were administered, with primary outcomes including changes in Dizziness Handicap Inventory (DHI) scores compared with baseline values. Objective variables included the DHI score and explanatory variables included demographic data, balance test results, head-up tilt (HUT) test results, vestibular test results and questionnaire survey results. Analysis of variance was used to assess the treatment effects of anti-CGRP mAbs, and multivariate regression analysis was performed to identify mAb responders.
RESULTS: After 6 months, the CGRP group showed significant improvements in DHI scores [0 versus 6 months, odds ratio (95% confidence interval): 22.01 (0.13-43.88)] and number of vertigo/dizziness attacks per month [0 versus 6 months: 10.28 (2.80-17.76)]. No significant difference was observed in the control group [DHI scores, 0 versus 6 months: 0.65 (-26.84 to 28.14); number of vertigo/dizziness attacks per month, 0 versus 6 months: - 8.07 (- 23.77 to 7.62)]. Multivariate regression analysis showed that autonomic function at baseline was associated with mAb response in patients [β estimates (95% confidence interval): 3.63 (0.21-7.06)].
CONCLUSIONS: Treatment with anti-CGRP mAbs was more effective than conventional treatment in preventing migraine in patients with VM. While the identified factors associated with treatment responsiveness offer valuable insights into personalised treatment approaches, further prospective studies are warranted to validate the findings due to our study\'s retrospective design and limited sample size.
摘要：
背景：偏头痛和头晕经常共存，前庭偏头痛（VM）表现为前庭症状和头痛。降钙素基因相关肽（CGRP）可能与运动诱发的症状有关；然而，关于使用抗CGRP单克隆抗体(mAb)治疗VM的研究产生了相互矛盾的结果.本研究旨在阐明抗CGRP单克隆抗体在VM治疗中的有效性。
方法：这项回顾性观察性队列研究，在2021年1月1日至2023年3月31日期间进行,评估了12例接受抗CGRPmAb治疗6个月的日本VM患者(CGRP组)和11例接受标准VM治疗并作为对照的日本患者.进行临床问卷调查和平衡测试，主要结局包括头晕障碍量表（DHI）评分与基线值相比的变化。客观变量包括DHI得分，解释变量包括人口统计数据，平衡测试结果，平视倾斜(HUT)测试结果,前庭测试结果和问卷调查结果。方差分析用于评估抗CGRP单克隆抗体的治疗效果，并进行多变量回归分析以鉴定mAb应答者。
结果：6个月后，CGRP组显着改善DHI评分[0对6个月，比值比（95％置信区间）：22.01（0.13-43.88）]和每月眩晕/头晕发作次数[0对6个月：10.28（2.80-17.76）]。对照组[DHI评分，0与6个月：0.65（-26.84至28.14）;每月眩晕/头晕发作次数，0与6个月：-8.07（-23.77至7.62）]。多变量回归分析显示，基线时自主神经功能与患者mAb反应相关[β估计值（95％置信区间）：3.63（0.21-7.06）]。
结论：抗CGRPmAb治疗在预防VM患者偏头痛方面比常规治疗更有效。虽然与治疗反应性相关的确定因素为个性化治疗方法提供了有价值的见解，由于我们研究的回顾性设计和有限的样本量,因此需要进一步的前瞻性研究来验证研究结果.
方法：这项回顾性观察性队列研究，在2021年1月1日至2023年3月31日期间进行,评估了12例接受抗CGRPmAb治疗6个月的日本VM患者(CGRP组)和11例接受标准VM治疗并作为对照的日本患者.进行临床问卷调查和平衡测试，主要结局包括头晕障碍量表（DHI）评分与基线值相比的变化。客观变量包括DHI得分，解释变量包括人口统计数据，平衡测试结果，平视倾斜(HUT)测试结果,前庭测试结果和问卷调查结果。方差分析用于评估抗CGRP单克隆抗体的治疗效果，并进行多变量回归分析以鉴定mAb应答者。
结果：6个月后，CGRP组显着改善DHI评分[0对6个月，比值比（95％置信区间）：22.01（0.13-43.88）]和每月眩晕/头晕发作次数[0对6个月：10.28（2.80-17.76）]。对照组[DHI评分，0与6个月：0.65（-26.84至28.14）;每月眩晕/头晕发作次数，0与6个月：-8.07（-23.77至7.62）]。多变量回归分析显示，基线时自主神经功能与患者mAb反应相关[β估计值（95％置信区间）：3.63（0.21-7.06）]。
结论：抗CGRPmAb治疗在预防VM患者偏头痛方面比常规治疗更有效。虽然与治疗反应性相关的确定因素为个性化治疗方法提供了有价值的见解，由于我们研究的回顾性设计和有限的样本量,因此需要进一步的前瞻性研究来验证研究结果.
