Department of Neurology, G B Pant institute of Post Graduate Medical Education and Research, Maulana Azad Medical College, New Delhi, India.
Department of Community Medicine, All India Institute of Medical sciences, New Delhi, India.
Cephalalgia. 2023 Feb;43(2):3331024221143541. doi: 10.1177/03331024221143541.
Greater occipital nerve blockade for the prevention of chronic migraine has a limited evidence base. A robust randomized double-blind, placebo-controlled trial is needed.
This double-blind, placebo-controlled, parallel-group trial, following a baseline period of four weeks, randomly assigned patients of chronic migraine 1:1 to receive four-weekly bilateral greater occipital nerve blockade with either 2 ml of 2% (40 mg) lidocaine (active group) or 2 ml of 0.9% saline (placebo) injections for 12 weeks. The primary and key secondary efficacy endpoints were a change from the baseline in the mean number of headache and migraine days and the achievement of ≥50% reduction in headache days from baseline across the weeks 9-12 respectively. Safety evaluations included the documentation and reporting of serious and other adverse events.
Twenty-two patients each were randomly allocated to the active and placebo group. Baseline demography and clinical characteristics were similar between the two groups. Mean headache and migraine days at baseline (±SD) were 23.4 ± 4.4 and 15.6 ± 5.7 days in the active group and 22.6 ± 5.0 and 14.6 ± 4.6 days in the placebo group respectively. The active group compared to the placebo had a significantly greater least-squares mean reduction in the number of headache and migraine days (-4.2 days [95% CI: -7.5 to -0.8; p = 0.018] and -4.7 days [95%CI: -7.7 to -1.7; p = 0.003] respectively). 40.9% of patients in the active group achieved ≥50% reduction in headache days as compared with 9.1% of patients receiving a placebo (p = 0.024). Overall, 64 mild and transient adverse events were reported by 16 patients in the active group and 15 in the placebo. No death or serious adverse events were reported.
Four-weekly greater occipital nerve blockade with 2% lidocaine for 12 weeks was superior to placebo in decreasing the average number of headache and migraine days in patients with chronic migraine with a good tolerability profile.Clinical trial.gov no. CTRI 2020/07/026709.
用于预防慢性偏头痛的枕大神经阻滞的证据有限。需要进行一项稳健的随机双盲、安慰剂对照试验。
这项双盲、安慰剂对照、平行组试验，在四周的基线期后，将慢性偏头痛患者以 1:1 的比例随机分配，接受为期 12 周的每四周一次的双侧枕大神经阻滞，分别接受 2ml 2%（40mg）利多卡因（活性组）或 2ml 0.9%生理盐水（安慰剂）注射。主要和关键次要疗效终点分别为从基线开始，头痛和偏头痛天数的平均值变化，以及在第 9-12 周期间从基线开始头痛天数减少 50%。安全性评估包括记录和报告严重不良事件和其他不良事件。
每组 22 名患者被随机分配到活性组和安慰剂组。两组的基线人口统计学和临床特征相似。活性组和安慰剂组的基线平均头痛和偏头痛天数分别为 23.4±4.4 天和 15.6±5.7 天，22.6±5.0 天和 14.6±4.6 天。与安慰剂组相比，活性组在头痛和偏头痛天数的减少方面有显著更大的最小二乘均数减少（分别为-4.2 天[95%CI：-7.5 至-0.8；p=0.018]和-4.7 天[95%CI：-7.7 至-1.7；p=0.003]）。与接受安慰剂的患者相比，40.9%的活性组患者达到了头痛天数减少 50%以上（p=0.024）。总体而言，活性组有 16 名患者和安慰剂组有 15 名患者报告了 64 例轻度和短暂的不良事件。没有死亡或严重不良事件报告。
2%利多卡因每四周一次进行 12 周的枕大神经阻滞治疗，在减少慢性偏头痛患者的平均头痛和偏头痛天数方面优于安慰剂，且具有良好的耐受性。临床试验编号 CTRI 2020/07/026709。
