Clinical outcomes and safety of Five Element Acupuncture for preventive treatment of primary headache disorders: a multi-center real-world longitudinal observational study.
15 affiliations
- 1Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, 100700 Beijing, China.
- 2The First Affiliated Hospital of Anhui University of Chinese Medicine, 230031 Hefei, Anhui, China.
- 3Henan Hospital of Integrated Traditional Chinese and Western Medicine, 450014 Zhengzhou, Henan, China.
- 4Kaixin TCM Clinic, 100194 Beijing, China.
- 5Tongyou Sanhe Jinhai Traditional Chinese Medicine Clinic, 201206 Shanghai, China.
- 6Binzhou Hospital of Traditional Chinese Medicine, 256613 Binzhou, Shandong, China.
- 7Jinshan Township Health Center, 165111 Huma County, Greater Khingan Range Prefecture, Heilongjiang, China.
- 8Tianjin Yuze Tang TCM Clinic, 300110 Tianjin, China.
- 9No. 208 Brigade of Nuclear Industry (Bohua Hospital of Baotou), 014010 Baotou, Inner Mongolia, China.
- 10Beijing Tongyousanhe Futai TCM Clinic, 100102 Beijing, China.
- 11Chengdu Tianrentang TCM Clinic, 610051 Chengdu, Sichuan, China.
- 12Beijing Zhengxintang TCM Clinic, 100010 Beijing, China.
- 13Shenzhen Hospital of Traditional Chinese Medicine, 518033 Shenzhen, Guangdong, China.
- 14Shenfu TCM Studio, 101300 Beijing, China.
- 15Shengyuan Five Element Acupuncture Studio, 450000 Zhengzhou, Henan, China.
Abstract
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.
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BibTeX
@article{cui2026clinical,
title = {{Clinical outcomes and safety of Five Element Acupuncture for preventive treatment of primary headache disorders: a multi-center real-world longitudinal observational study.}},
author = {Shuo Cui and Yaping Liu and Jingjing Wang and Wenqian Ma and Zhenshan Luo and Ziwei Song and Zhongjie Chen and Jincao Zhou and Yuying Wang and Qianfeng Huang and Chao Yu and Yanping Che and Zhishuai Liu and Yaoci Song and Yuqing Yin and Ruijuan Liu and Huan Wang and Dehua Tian and Fuyang Xian and Xiaohui Zhan and Jiping Li and Shengyuan Zhou},
journal = {Journal of oral \& facial pain and headache},
year = {2026},
month = sep,
doi = {10.22514/jofph.2026.064},
url = {https://europepmc.org/article/MED/42895011},
note = {CC BY},
}
RIS
TY - JOUR
TI - Clinical outcomes and safety of Five Element Acupuncture for preventive treatment of primary headache disorders: a multi-center real-world longitudinal observational study.
AU - Shuo Cui
AU - Yaping Liu
AU - Jingjing Wang
AU - Wenqian Ma
AU - Zhenshan Luo
AU - Ziwei Song
AU - Zhongjie Chen
AU - Jincao Zhou
AU - Yuying Wang
AU - Qianfeng Huang
AU - Chao Yu
AU - Yanping Che
AU - Zhishuai Liu
AU - Yaoci Song
AU - Yuqing Yin
AU - Ruijuan Liu
AU - Huan Wang
AU - Dehua Tian
AU - Fuyang Xian
AU - Xiaohui Zhan
AU - Jiping Li
AU - Shengyuan Zhou
PY - 2026
DA - 2026/09/12
JO - Journal of oral & facial pain and headache
DO - 10.22514/jofph.2026.064
UR - https://europepmc.org/article/MED/42895011
AB - 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.
SN - 2333-0384
SN - 2333-0376
ER -