中医药治疗偏头痛临床研究注册特征分析

Analysis of the registration characteristics of clinical trials on migraine treated with traditional Chinese medicine

关键词:  偏头痛  中医药治疗  临床研究注册  特征分析

Key words:  migraine  traditional Chinese medicine therapy  clinical trial registration  characteristics analysis

摘要:

[目的] 探索中医药治疗偏头痛的临床研究注册特征与发展趋势。[方法] 从中国临床试验注册中心、美国临床试验注册中心以及国际传统医学临床试验注册平台检索并提取各数据库建立之日起至2025年4月22日注册的中医药治疗偏头痛临床研究的相关信息。采用描述性统计分析，计数资料以频数及百分数（n，%）进行统计描述。[结果] 纳入88项中医药治疗偏头痛相关的临床研究。研究类型以干预性研究（83项，94.3%）为多，普遍采用随机平行对照设计（73项，83.0%）；研究人群以无先兆偏头痛患者（39项，44.3%）为主；干预措施主要分中医内治（19项，21.6%）、中医外治（63项，71.6%）和内外联合治疗（6项，6.8%）3类，以针刺（52项，59.1%）为主；高频主要结局指标（＞10次）依次为头痛发作频数、发作天数、磁共振指标、视觉模拟评分。[结论] 中医药治疗偏头痛相关临床研究注册数量呈现持续增长趋势，但注册信息规范性不足，这提示研究者严格遵循国际注册标准填写注册信息。

Abstract:

[Objective] To explore the registration characteristics and development trends of clinical trials on the prevention and treatment of migraine with traditional Chinese medicine. [Methods] The information on clinical trials related to the treatment of migraine with Chinese medicine was searched and extracted from the Chinese Clinical Trial Registry，the U.S. Clinical Trial Registry，and the International Traditional Medicine Clinical Trial Registry Platform from the date of establishment of the respective databases until April 22，2025. Descriptive statistical analysis was adopted. Count data were statistically described by frequency and percentage（n，%）. [Results] A total of 88 clinical trials on migraine treated with traditional Chinese medicine were included. Most of the registered trials were interventional studies（83，94.3%），and a randomized parallel-controlled design was predominantly used（73，83.0%）. The study population primarily consisted of patients with migraine without aura（39，44.3%）. Interventions were mainly categorized into internal Chinese medicine treatments（19，21.6%），external Chinese medicine treatments（63，71.6%），and combined internal and external treatments（6，6.8%），with acupuncture being the most common（52，59.1%）. The most frequently used primary outcome indicators（>10 studies） were，in descending order：headache attack frequency，number of headache days，magnetic resonance imaging indices，and the visual analog scale score. [Conclusion] The number of registered clinical trials on migraine treated with traditional Chinese medicine continues to grow. However，the standardization of registration information needs improvement，suggesting that researchers should strictly adhere to international registration standards when completing registration details.