The clinical efficacy of auricular acupuncture in the treatment of frequent episodic tension-type headache: a single-blind randomized controlled trial

Abstract

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_ACA, V_MCA, and V_PCA, 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_ACA (85.5 (85, 86) vs. 83 (83, 84) at the 4th week, P < 0.001), V_PCA (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.

Keywords: Auricular acupoints; Auricular acupuncture; Clinical efficacy; Frequent episodic tension-type headache.

Fig. 1

Clinical trial flow chart: Participant Flow Diagram. A total of 100 participants underwent initial screening for eligibility. Of these, 20 were excluded based on predefined criteria. The remaining 80 eligible participants were randomly assigned to either the treatment group (n = 40), which received auricular acupuncture, or the control group (n = 40), which received sham acupuncture. Four participants in the treatment group and three in the control group discontinued the intervention or were lost to follow-up. The final analysis included 73 participants, with efficacy and safety assessments adhering to the intention-to-treat (ITT) principle

Fig. 2

Acupuncture Point Location Diagram and Auricular Acupuncture Devices Used in the Study. The national standard auricular acupoint refers to the name and standard positioning of auricular acupoint (GB/T 13734 − 2008) issued by the National Standards Administration of the People’s Republic of China. Auricular acupuncture products from Beijing Luoyashanchuan Medical Device Co., Ltd. were used in this study

Fig. 3

Time course of the change from baseline in co-primary outcomes. a Time course of the change from baseline in VAS score, presented as median (QL [lower quartile]∼QU [upper quartile]) at each time point. b Time course of the change from baseline in Headache index, presented as median (QL∼QU) at each time point. c Time course of the change from baseline in HAMA score, presented as mean ± SD at each time point