Zhou Li, Zhang Zhe, Li Geng, Liao Shaojun, Zhou Hongfei, Wang Pengqin, Liu Guanghui, Bai Li, Wen Zehuai
Second Clinical Medical College, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.
Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China.
Evid Based Complement Alternat Med. 2020 Sep 11;2020:5653169. doi: 10.1155/2020/5653169. eCollection 2020.
Tension-type headache (TTH) is the most common headache disorder. Current treatments for TTH have been reported to be associated with insufficient long-term benefits and unwanted adverse events (AEs). The Chinese herbal formula Xuefu Zhuyu (XFZY) has been utilized in TTH treatment, but the evidence supporting its efficacy remains unclear. This study will evaluate the efficacy and safety of XFZY for TTH.
This multicenter, double-blind, randomized, placebo-controlled trial will be undertaken in China. A total of 174 eligible participants will be randomly assigned to either an XFZY group or a placebo group (20 ml each dose, three times daily for 4 weeks) at a ratio of 1 : 1. The primary outcome is the change in mean headache intensity measured by a 10 cm visual analogue scale (VAS). Secondary outcomes include the area-under-the headache curve (AUC), headache frequency, rescue medication use, pattern measurement, quality of life measured by the EuroQol-5-Dimensions-5-Level (EQ-5D-5L), global evaluation of medication, and health economic indexes. . The results of the study are expected to provide evidence of high methodological and reporting quality on the efficacy and safety of XFZY for TTH. This trail is registered with ChiCTR1900026716 (registered on 19 October, 2019).
紧张型头痛（TTH）是最常见的头痛疾病。据报道，目前治疗TTH的方法长期疗效不足且存在不良事件（AE）。中药方剂血府逐瘀（XFZY）已用于TTH治疗，但其疗效的证据仍不明确。本研究将评估XFZY治疗TTH的疗效和安全性。
本多中心、双盲、随机、安慰剂对照试验将在中国进行。总共174名符合条件的参与者将按1∶1的比例随机分配到XFZY组或安慰剂组（每次剂量20毫升，每日三次，共4周）。主要结局是用10厘米视觉模拟量表（VAS）测量的平均头痛强度变化。次要结局包括头痛曲线下面积（AUC）、头痛频率、急救药物使用、模式测量、用欧洲五维五水平健康量表（EQ-5D-5L）测量的生活质量、药物总体评价和卫生经济指标。本研究结果有望为XFZY治疗TTH的疗效和安全性提供高质量的方法学和报告证据。本试验已在中国临床试验注册中心注册，注册号为ChiCTR1900026716（2019年10月19日注册）。
