{ "abstract": "Background\n\nTo observe the real-world association of Five Element Acupuncture (FEA) with symptom improvement when used for the preventive treatment of primary headache disorders.Methods\n\nThis 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\n\nNinety-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\n\nThis 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\n\nRegistration No.: ChiCTR2200061878.", "abstract_shown": true, "affiliations": [ "Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, 100700 Beijing, China.", "The First Affiliated Hospital of Anhui University of Chinese Medicine, 230031 Hefei, Anhui, China.", "Henan Hospital of Integrated Traditional Chinese and Western Medicine, 450014 Zhengzhou, Henan, China.", "Kaixin TCM Clinic, 100194 Beijing, China.", "Tongyou Sanhe Jinhai Traditional Chinese Medicine Clinic, 201206 Shanghai, China.", "Binzhou Hospital of Traditional Chinese Medicine, 256613 Binzhou, Shandong, China.", "Jinshan Township Health Center, 165111 Huma County, Greater Khingan Range Prefecture, Heilongjiang, China.", "Tianjin Yuze Tang TCM Clinic, 300110 Tianjin, China.", "No. 208 Brigade of Nuclear Industry (Bohua Hospital of Baotou), 014010 Baotou, Inner Mongolia, China.", "Beijing Tongyousanhe Futai TCM Clinic, 100102 Beijing, China.", "Chengdu Tianrentang TCM Clinic, 610051 Chengdu, Sichuan, China.", "Beijing Zhengxintang TCM Clinic, 100010 Beijing, China.", "Shenzhen Hospital of Traditional Chinese Medicine, 518033 Shenzhen, Guangdong, China.", "Shenfu TCM Studio, 101300 Beijing, China.", "Shengyuan Five Element Acupuncture Studio, 450000 Zhengzhou, Henan, China." ], "article_type": "research article", "arxiv": null, "author_total": 22, "authors": [ { "affs": [ 0 ], "name": "Shuo Cui" }, { "affs": [ 0 ], "name": "Yaping Liu" }, { "affs": [ 0 ], "name": "Jingjing Wang" }, { "affs": [ 0 ], "name": "Wenqian Ma" }, { "affs": [ 0 ], "name": "Zhenshan Luo" }, { "affs": [ 0 ], "name": "Ziwei Song" }, { "affs": [ 0 ], "name": "Zhongjie Chen" }, { "affs": [ 0 ], "name": "Jincao Zhou" }, { "affs": [ 1 ], "name": "Yuying Wang" }, { "affs": [ 2 ], "name": "Qianfeng Huang" }, { "affs": [ 3 ], "name": "Chao Yu" }, { "affs": [ 4 ], "name": "Yanping Che" }, { "affs": [ 5 ], "name": "Zhishuai Liu" }, { "affs": [ 6 ], "name": "Yaoci Song" }, { "affs": [ 7 ], "name": "Yuqing Yin" }, { "affs": [ 8 ], "name": "Ruijuan Liu" }, { "affs": [ 9 ], "name": "Huan Wang" }, { "affs": [ 10 ], "name": "Dehua Tian" }, { "affs": [ 11 ], "name": "Fuyang Xian" }, { "affs": [ 12 ], "name": "Xiaohui Zhan" }, { "affs": [ 13 ], "name": "Jiping Li" }, { "affs": [ 14 ], "name": "Shengyuan Zhou" } ], "bibtex": "https://research.draconitic.com/paper/1tb5cp5nqcr92.bib", "cited_by": 0, "doi": "10.22514/jofph.2026.064", "fulltext_url": "https://europepmc.org/articles/PMC13678558", "id": "1tb5cp5nqcr92", "issns": [ "2333-0384", "2333-0376" ], "landing_url": "https://europepmc.org/article/MED/42895011", "language": "eng", "licence": "CC-BY", "licence_label": "CC BY", "licence_source": "article", "licence_url": "https://creativecommons.org/licenses/by/4.0/", "metadata_licence": null, "native_subjects": [ [ "openalex", "2707|Acupuncture Treatment Research Studies" ] ], "openalex": "W7212273483", "pdf_url": "https://europepmc.org/articles/PMC13678558?pdf=render", "pmcid": "PMC13678558", "pmid": "42895011", "published": "2026-09-12", "publisher": null, "ris": "https://research.draconitic.com/paper/1tb5cp5nqcr92.ris", "sources": [ { "first_seen": "2026-10-30T12:19:41Z", "native_id": "MED:42895011", "source": "europepmc", "url": "https://europepmc.org/article/MED/42895011" } ], "subjects": [ { "field": "medicine", "origin": "openalex:2707|Acupuncture Treatment Research Studies", "subfield": "general" } ], "title": "Clinical outcomes and safety of Five Element Acupuncture for preventive treatment of primary headache disorders: a multi-center real-world longitudinal observational study.", "title_text": "Clinical outcomes and safety of Five Element Acupuncture for preventive treatment of primary headache disorders: a multi-center real-world longitudinal observational study.", "type": "peer-reviewed", "updated_at": "2026-10-30T12:19:41Z", "url": "https://research.draconitic.com/paper/1tb5cp5nqcr92", "venue": "Journal of oral & facial pain and headache", "versions": [] }