Jin Xiaxia, Xu Ziwen, Gao Tao, Wang Gaofeng, Dong Wendi, Jin Junyi, Yan Yongmei
National Resource Center for Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing, 100700, China.
Swiss University of Traditional Chinese Medicine, Bad Zurzach, 5330, Switzerland.
BMC Complement Med Ther. 2025 Aug 21;25(1):311. doi: 10.1186/s12906-025-05063-x.
BACKGROUND: Frequent episodic tension-type headache (FETTH) is a significant public-health concern. Scientific research has demonstrated that acupuncture can improve the clinical symptoms of FETTH. PURPOSE: This study aimed to compare the efficacy and safety of auricular acupuncture and sham acupuncture in treating FETTH. METHODS: This was a randomized controlled trial. Participants with FETTH were randomly assigned in a 1:1 ratio to receive auricular acupuncture or sham acupuncture for 4 weeks, with follow-up lasting for up to 24 weeks. The primary outcomes were measured using the headache index and visual analog scale (VAS) score. Secondary outcomes included the Hamilton Anxiety Scale (HAMA) score, Hamilton Depression Scale (HAMD) score, blood flow velocity in the anterior cerebral artery (ACA), middle cerebral artery (MCA), and posterior cerebral artery (PCA) (V, V, and V, respectively), and the usage of acute headache medications. Adverse events were also recorded to assess safety. RESULTS: Compared with the sham acupuncture group, the auricular acupuncture group showed significant improvements in VAS score (2 (1.25, 2) vs. 3 (2, 3.5) at 24 h, P < 0.001; 2 (1.25, 2) vs. 2 (2, 3) at the 2nd week, P = 0.004; 2 (1, 2) vs. 2 (1.5, 3) at the 4th week, P = 0.015), headache index (4 (2, 7) vs. 7 (4, 9) at the 4th week, P = 0.016), HAMA score (11.69 ± 2.70) vs. (14.24 ± 3.20) at the 4th week, P < 0.001; (9.83 ± 2.71) vs. (11.95 ± 2.59) at the 8th week, P = 0.001; (9.67 ± 2.65) vs. (11.76 ± 3.00) at the 24th week, P = 0.002), HAMD score ((14.25 ± 2.68) vs. (15.89 ± 3.48) at the 4th week, P = 0.027,) V (85.5 (85, 86) vs. 83 (83, 84) at the 4th week, P < 0.001), V (82 (81, 83) vs. 78 (77, 79) at the 4th week, P < 0.001), and usage of acute headache medications (8 (7, 10) vs. 9 (8, 11) at the 4th week, P = 0.030). The incidence of adverse events was similar between the two groups (P = 1.000). CONCLUSION: This study found that auricular acupuncture effectively improved the clinical symptoms of FETTH and had relatively fewer side effects. TRIAL REGISTRATION: The study was retrospectively registered in the International Traditional Medicine Clinical Trial Registry (ITMCTR2025000363) on January 20, 2025.
背景：频发发作性紧张型头痛（FETTH）是一个重大的公共卫生问题。科学研究表明，针灸可以改善FETTH的临床症状。 目的：本研究旨在比较耳针与假针灸治疗FETTH的疗效和安全性。 方法：这是一项随机对照试验。将FETTH患者按1:1比例随机分配，接受耳针或假针灸治疗4周，随访长达24周。主要结局指标采用头痛指数和视觉模拟量表（VAS）评分进行测量。次要结局指标包括汉密尔顿焦虑量表（HAMA）评分、汉密尔顿抑郁量表（HAMD）评分、大脑前动脉（ACA）、大脑中动脉（MCA）和大脑后动脉（PCA）的血流速度（分别为V、V和V），以及急性头痛药物的使用情况。还记录不良事件以评估安全性。 结果：与假针灸组相比，耳针组在VAS评分（24小时时为2（1.25，2）对3（2，3.5），P＜0.001；第2周时为2（1.25，2）对2（2，3），P = 0.004；第4周时为2（1，2）对2（1.5，3），P = 0.015）、头痛指数（第4周时为4（2，7）对7（4，9），P = 0.016）、HAMA评分（第4周时为11.69±2.70对（14.24±3.20），P＜0.001；第8周时为（9.83±2.71）对（11.95±2.59），P = 0.001；第24周时为（9.67±2.65）对（11.76±3.00），P = 0.002）、HAMD评分（第4周时为（14.25±2.68）对（15.89±3.48），P = 0.027）、V（第4周时为85.5（85，86）对83（83，84），P＜0.001）、V（第4周时为82（81，83）对78（77，79），P＜0.001）以及急性头痛药物使用情况（第4周时为8（7，10）对9（8，11），P = 0.030）方面有显著改善。两组不良事件发生率相似（P = 1.000）。 结论：本研究发现耳针能有效改善FETTH的临床症状且副作用相对较少。 试验注册：该研究于2025年1月20日在国际传统医学临床试验注册中心（ITMCTR2025000363）进行回顾性注册。
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