Xiaxia Jin, Ziwen Xu, Tao Gao, Gaofeng Wang, Wendi Dong, Junyi Jin, Yongmei Yan
{"title":"耳针治疗频繁发作性紧张性头痛的临床疗效:单盲随机对照试验。","authors":"Xiaxia Jin, Ziwen Xu, Tao Gao, Gaofeng Wang, Wendi Dong, Junyi Jin, Yongmei Yan","doi":"10.1186/s12906-025-05063-x","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Purpose: </strong>This study aimed to compare the efficacy and safety of auricular acupuncture and sham acupuncture in treating FETTH.</p><p><strong>Methods: </strong>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<sub>ACA</sub>, V<sub>MCA</sub>, and V<sub>PCA</sub>, respectively), and the usage of acute headache medications. Adverse events were also recorded to assess safety.</p><p><strong>Results: </strong>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<sub>ACA</sub> (85.5 (85, 86) vs. 83 (83, 84) at the 4th week, P < 0.001), V<sub>PCA</sub> (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).</p><p><strong>Conclusion: </strong>This study found that auricular acupuncture effectively improved the clinical symptoms of FETTH and had relatively fewer side effects.</p><p><strong>Trial registration: </strong>The study was retrospectively registered in the International Traditional Medicine Clinical Trial Registry (ITMCTR2025000363) on January 20, 2025.</p>","PeriodicalId":9128,"journal":{"name":"BMC Complementary Medicine and Therapies","volume":"25 1","pages":"311"},"PeriodicalIF":3.4000,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12369207/pdf/","citationCount":"0","resultStr":"{\"title\":\"The clinical efficacy of auricular acupuncture in the treatment of frequent episodic tension-type headache: a single-blind randomized controlled trial.\",\"authors\":\"Xiaxia Jin, Ziwen Xu, Tao Gao, Gaofeng Wang, Wendi Dong, Junyi Jin, Yongmei Yan\",\"doi\":\"10.1186/s12906-025-05063-x\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>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.</p><p><strong>Purpose: </strong>This study aimed to compare the efficacy and safety of auricular acupuncture and sham acupuncture in treating FETTH.</p><p><strong>Methods: </strong>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<sub>ACA</sub>, V<sub>MCA</sub>, and V<sub>PCA</sub>, respectively), and the usage of acute headache medications. Adverse events were also recorded to assess safety.</p><p><strong>Results: </strong>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<sub>ACA</sub> (85.5 (85, 86) vs. 83 (83, 84) at the 4th week, P < 0.001), V<sub>PCA</sub> (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).</p><p><strong>Conclusion: </strong>This study found that auricular acupuncture effectively improved the clinical symptoms of FETTH and had relatively fewer side effects.</p><p><strong>Trial registration: </strong>The study was retrospectively registered in the International Traditional Medicine Clinical Trial Registry (ITMCTR2025000363) on January 20, 2025.</p>\",\"PeriodicalId\":9128,\"journal\":{\"name\":\"BMC Complementary Medicine and Therapies\",\"volume\":\"25 1\",\"pages\":\"311\"},\"PeriodicalIF\":3.4000,\"publicationDate\":\"2025-08-21\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12369207/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"BMC Complementary Medicine and Therapies\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1186/s12906-025-05063-x\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"INTEGRATIVE & COMPLEMENTARY MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Complementary Medicine and Therapies","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12906-025-05063-x","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"INTEGRATIVE & COMPLEMENTARY MEDICINE","Score":null,"Total":0}
引用次数: 0
摘要
背景:频繁发作性紧张性头痛(FETTH)是一个重要的公共卫生问题。科学研究表明,针灸可以改善胎儿妊娠的临床症状。目的:比较耳针与假针治疗胎儿妊娠综合征的疗效和安全性。方法:采用随机对照试验。FETTH患者按1:1的比例随机分配接受耳针或假针灸治疗4周,随访时间长达24周。主要结局采用头痛指数和视觉模拟量表(VAS)评分进行测量。次要结果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VACA、VMCA和VPCA)以及急性头痛药物的使用情况。不良事件也被记录下来以评估安全性。结果:与假针组比较,耳针组24 h VAS评分(2分(1.25,2)比3分(2,3.5),第4周paca评分(85.5分(85,86)比83分(83,84),第4周ppca评分(82分(81,83)比78分(77,79),P均有显著改善。结论:本研究发现耳针可有效改善胎儿妊娠期临床症状,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)回顾性注册。
The clinical efficacy of auricular acupuncture in the treatment of frequent episodic tension-type headache: a single-blind randomized controlled trial.
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) (VACA, VMCA, and VPCA, 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,) VACA (85.5 (85, 86) vs. 83 (83, 84) at the 4th week, P < 0.001), VPCA (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.