Ratanasampil is more effective than flunarizine in relieving migraine

<b>Aims:</b> Migraine is a common neurological disorder with high incidence in population. This study aimed to investigate the therapeutic efficacy of Tibetan medicine Ratanasampil (RNSP) and to identify the serum biomarkers for diagnosis and response assessment.<b>Materials and methods</b>: We prospectively recruited 108 migraine patients living at high altitude (2,260 m), including 40 patients for RNSP group, 40 patients for flunarizine (FLZ) group, and 28 patients for placebo group. Serum levels of 5-hydroxytryptamine (5-HT), brain-derived neurotrophic factor (BDNF), calcitonin gene related peptide (CGRP), nerve growth factor (NGF) and β-endorphin (β-EP) before and after therapy were measured.<b>Results:</b> In comparison with placebo, both FLZ and RNSP significantly reduced the migraine days, HIT-6 score and verbal rating scale, headache intensity, duration, accompanying symptoms and headache score in four and eight weeks treatment. RNSP showed no significant difference to FLZ in the above parameters after four weeks treatment, but showed significantly better relief after eight weeks treatment. The overall effective rate of RNSP (92.5%) was also significantly higher than FLZ (74.4%, p &lt; 0.05), mainly due to significantly higher ratio of patients with full recovery. The serum levels of biomarkers, including 5-HT, BDNF, NGF and β-EP, significantly elevated after eight weeks of treatment with RNSP, whereas the level of CGRP significantly decreased. The serum level of 5-HT exhibited significantly bigger percentage changes than other markers.<b>Conclusion:</b> In conclusion, RNSP was more effective than FLZ in relieving migraine after eight weeks continuous treatment. Serum 5-HT, BDNF, CGRP, NGF and β-EP were effective markers reflecting the response to RNSP and FLZ therapy.

<b>研究目的：</b>偏头痛是一种人群发病率较高的常见神经系统疾病。本研究旨在探讨藏药拉坦萨皮尔（Ratanasampil, RNSP）的治疗功效，并筛选可用于偏头痛诊断及疗效评估的血清生物标志物。<b>材料与方法：</b>本研究前瞻性招募了108名居住于海拔2260米高海拔地区的偏头痛患者，其中拉坦萨皮尔组（RNSP组）40例、氟桂利嗪（flunarizine, FLZ）组40例、安慰剂组28例。检测三组患者治疗前后血清中5-羟色胺（5-hydroxytryptamine, 5-HT）、脑源性神经营养因子（brain-derived neurotrophic factor, BDNF）、降钙素基因相关肽（calcitonin gene related peptide, CGRP）、神经生长因子（nerve growth factor, NGF）及β-内啡肽（β-endorphin, β-EP）的水平。<b>研究结果：</b>与安慰剂组相比，FLZ组与RNSP组在4周及8周治疗后，均显著降低了偏头痛发作天数、HIT-6评分、语言评定量表得分、头痛强度、头痛持续时间、伴随症状及头痛积分。治疗4周后，RNSP组与FLZ组的上述各项参数无显著差异；但治疗8周后，RNSP组的头痛缓解效果显著更优。RNSP组的总有效率（92.5%）亦显著高于FLZ组（74.4%，p<0.05），这主要得益于RNSP组完全康复的患者比例更高。经RNSP治疗8周后，患者血清中5-HT、BDNF、NGF及β-EP水平显著升高，而CGRP水平显著降低；其中血清5-HT的变化百分比显著高于其他标志物。<b>研究结论：</b>综上，连续8周治疗后，RNSP缓解偏头痛的疗效优于FLZ。血清5-HT、BDNF、CGRP、NGF及β-EP可作为反映RNSP与FLZ治疗响应的有效生物标志物。