A single-blind randomized controlled trial (RCT) compared auricular acupuncture with sham acupuncture for frequent episodic tension-type headache (FETTH).
The auricular acupuncture group showed significant advantages on VAS at 24 hours, week 2, and week 4; on the headache index at week 4; on HAMA at weeks 4, 8, and 24; and in reduced short-term medication use. Adverse events were rare and similar between groups.
Background: Tension-Type Headaches
Tension-type headache (TTH) is the most prevalent primary headache, typically bilateral, mild to moderate, and lasting 30 minutes to 7 days. Globally, headaches affect ~52% of people, with TTH around 26% of cases; FETTH occurs in roughly 21.6% annually. These headaches often impair work and daily life, underscoring the need for timely intervention.
Conventional options include NSAIDs and antidepressants, but adverse effects and compliance issues are common. This has driven interest in non-pharmacologic therapies such as acupuncture.
Auricular Acupuncture Brief Overview
From a traditional perspective, the ear reflects the body via meridian networks. Modern research suggests auricular stimulation can activate the vagus nerve pathway and modulate pain. As a technique, auricular acupuncture is low-cost with minimal reported adverse reactions compared to many drugs.
Patients and Groups in the Study
Researchers enrolled outpatients at the Affiliated Hospital of Shaanxi University of Chinese Medicine (Xianyang, China). Eighty(80) participants meeting inclusion criteria were randomized 1:1 to auricular acupuncture or sham (40 per group). The study had ethics approval, and participants provided informed consent. A total of 100 were screened. randomized and 73 completed assessments for analysis.
Participants were followed for 24 weeks, with primary outcomes including the headache index and visual analogue scale (VAS) and secondary outcomes covering anxiety (HAMA), depression (HAMD), cerebral arterial blood-flow velocities, and acute medication use.
Auricular needling targeted six standardized ear points chosen to match headache topography and modulate autonomic tone:
Jiaogan (AH6a, “Sympathetic”)
Pizhixia (AT4, “Subcortex”)
Shenmen (TF4), plus E (AT1, “Forehead”)
Nie (AT2, “Temporal”)
Zhen (AT3, “Occiput”)
For unilateral pain, clinicians treated the ipsilateral ear (same side of the body); for bilateral pain (both sides of the body), they used points on both ears.
Sessions used small intradermal auricular needles fixed with medical tape to provide sustained stimulation, and participants were instructed to press the buried points between visits. Treatments were delivered twice weekly for four weeks.
Outcomes: VAS and Other Measures
Pain (VAS) & Headache Index. Compared with sham, auricular acupuncture produced a lower VAS scores at 24 hours, week 2, and week 4; by week 8, between-group VAS differences were not significant. The headache index was also lower in the auricular group at week 4.
Anxiety & Depression. Anxiety (HAMA) improved more in the auricular group at weeks 4, 8, and 24, and depression (HAMD) was better at week 4. These findings suggest benefits that extend beyond pain intensity.
Cerebral Blood-Flow Metrics. Posterior cerebral artery velocity (VPCA) increased more with auricular acupuncture by week 4, while middle cerebral artery velocity (VMCA) showed no between-group difference.
Medication Use
Patients in the auricular group used fewer acute headache medications at week 4 (median 8 vs. 9 doses), though the change-from-baseline comparison at that point was not statistically significant.
Clinical Response & Safety
The total effective rate over the 4-week treatment phase was higher with auricular acupuncture (91.67% vs. 64.86%). Only one mild adverse event occurred in each group, and the overall incidence did not differ.
Bottom Line
In this single-center, single-blind RCT from Xianyang, auricular acupuncture outperformed sham on early pain relief, functional indices, anxiety, selected blood-flow measures, and short-term medication use—while maintaining a favorable safety profile. The authors note typical limitations (single site, modest sample, challenges to double blinding) and call for larger, multi-center trials.
References:
Jin X, Xu Z, Gao T, et al. “The clinical efficacy of auricular acupuncture in the treatment of frequent episodic tension-type headache: a single-blind randomized controlled trial.” BMC Complementary Medicine and Therapies. 2025;25:311. Open-access CC BY 4.0.
https://pubmed.ncbi.nlm.nih.gov/40842010/