Clinical outcomes and safety of Five Element Acupuncture for preventive treatment of primary headache disorders: a multi-center real-world longitudinal observational study

Background: To observe the real-world association of Five Element Acupuncture (FEA) with symptom improvement when used for the preventive treatment of primary headache disorders. Methods: This prospective case series study was conducted across multiple centers in China. Patients diagnosed with migraine, tension-type headache (TTH), or trigeminal autonomic cephalalgias (TACs) according to the International Classification of Headache Disorders, Third Edition (ICHD-3), received standardized FEA treatment once every 1–2 weeks for 12 weeks, followed by a 12-week follow-up. Outcomes included headache days per 4 weeks, headache frequency, headache intensity (visual analog scale, VAS), total analgesic units, and headache-related quality of life (Headache Impact Test-6, HIT-6). Safety was assessed by recording acupuncture-related adverse events (AEs). Linear mixed models were used for analysis. Results: Ninety-three participants were included in the intention-to-treat analysis. Headache days were significantly reduced from baseline to the 12-week treatment (p < 0.001, d = −2.01, 95% Confidence Intervals (CI) (−2.37, −1.65)) and 12-week follow-up (p < 0.001, d = −2.50, 95% CI (−2.99, −2.01)) time points. Significant improvements were also noted in headache frequency, VAS scores, total analgesic units, and HIT-6 scores (all p < 0.001). Headache days and HIT-6 scores showed further significant improvement during the follow-up period compared to the end of treatment (p = 0.009 and p < 0.001, respectively). No acupuncture-related AEs were reported. Conclusions: This real-world exploratory observational study suggests that FEA is associated with significant improvements in headache days, headache frequency, headache intensity, analgesic use, and quality of life, with sustained effects noted during follow-up. These findings provide preliminary observational evidence that may inform the design of future randomized controlled trials. Clinical Trial Registration: Registration No.: ChiCTR2200061878.

Primary headache; Five Element Acupuncture; Psychosomatic conditions; Real-world study

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