Acupuncture as adjunctive therapy for acute cerebral infarction: a randomized clinical trial

BackgroundAcute cerebral infarction (ACI) is the second leading cause of death and the major cause of disability worldwide, and there is an increasing interest in non-pharmacological treatments. Acupuncture has promising effects on ACI, but its efficacy and safety need to be verified through well-de...

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Main Authors: Jiang-Peng Cao, Xin-Yue Du, Xiao-Xi Liu, Meng-Han Li, Man Zhang, Sheng-Xuan Guo, Qiu-Han Cai, Jia-Xin Zhang, Shan-Shan Sun, Jia-Wei Han, Lin-Ling Chen, Na Zheng, Lan-Yu Jia, Gui-Ping Li, Yuan-Hao Du
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-04-01
Series:Frontiers in Neurology
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Online Access:https://www.frontiersin.org/articles/10.3389/fneur.2025.1509204/full
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author Jiang-Peng Cao
Jiang-Peng Cao
Jiang-Peng Cao
Xin-Yue Du
Xiao-Xi Liu
Xiao-Xi Liu
Meng-Han Li
Meng-Han Li
Man Zhang
Sheng-Xuan Guo
Sheng-Xuan Guo
Qiu-Han Cai
Qiu-Han Cai
Jia-Xin Zhang
Jia-Xin Zhang
Jia-Xin Zhang
Shan-Shan Sun
Shan-Shan Sun
Shan-Shan Sun
Jia-Wei Han
Lin-Ling Chen
Na Zheng
Lan-Yu Jia
Gui-Ping Li
Gui-Ping Li
Yuan-Hao Du
Yuan-Hao Du
author_facet Jiang-Peng Cao
Jiang-Peng Cao
Jiang-Peng Cao
Xin-Yue Du
Xiao-Xi Liu
Xiao-Xi Liu
Meng-Han Li
Meng-Han Li
Man Zhang
Sheng-Xuan Guo
Sheng-Xuan Guo
Qiu-Han Cai
Qiu-Han Cai
Jia-Xin Zhang
Jia-Xin Zhang
Jia-Xin Zhang
Shan-Shan Sun
Shan-Shan Sun
Shan-Shan Sun
Jia-Wei Han
Lin-Ling Chen
Na Zheng
Lan-Yu Jia
Gui-Ping Li
Gui-Ping Li
Yuan-Hao Du
Yuan-Hao Du
author_sort Jiang-Peng Cao
collection DOAJ
description BackgroundAcute cerebral infarction (ACI) is the second leading cause of death and the major cause of disability worldwide, and there is an increasing interest in non-pharmacological treatments. Acupuncture has promising effects on ACI, but its efficacy and safety need to be verified through well-designed randomized clinical trials. We aimed to investigate the efficacy and safety of acupuncture as adjunctive therapy to improve neurological function in patients with ACI.MethodsThe multicenter, sham-controlled, patient- and assessor-blinded randomized controlled trial was conducted in 4 tertiary hospitals in China from January to September 2024. All participants received standard care as recommended by the guidelines and were randomly assigned (1:1:1) to manual acupuncture (MA), sham acupuncture (SA), or standard care (SC) only. Participants in the MA and SA groups received acupuncture treatment 6 times weekly for 2 weeks for a total of 12 sessions. The primary outcome was the change in the National Institutes of Health Stroke Scale score from baseline to 14 days. Safety outcomes included adverse events and serious adverse events.ResultsA total of 132 patients (median [IQR] age, 65 [58–69] years; 96 men [72.73%]), with a median (IQR) baseline National Institutes of Health Stroke Scale score of 11 (9–12) points, were included in the intention-to-treat analysis. Ten patients withdrew during the 14-day intervention, and another 7 patients withdrew during the 90-day follow-up. During the 14-day intervention, the median neurological impairment was significantly improved in the MA group compared to the SA group (4 [3, 5] vs. 3 [1.25, 4] points; Cohen’s d, 0.76; 95% CI, 0.33 to 1.19; p = 0.001). Adverse events occurred relatively equally between the MA and SA groups (19 [43.2%] vs. 13 [29.5%]; relative risk, 1.46; 95% CI, 0.83 to 2.58; p = 0.184).ConclusionTwelve sessions of MA were safe and effective in improving the neurological function of patients with ACI. The results of this trial indicate that MA can be recommended as a routine, supplemental therapy for improving neurological function in patients with ACI.Clinical trial registrationChiCTR2300079204 (Chinese Clinical Trial Registry, http://www.chictr.org.cn, registered on 27/12/2023).
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spelling doaj-art-5e849f5e628e4c6d93071db115f9f6f02025-08-20T02:09:17ZengFrontiers Media S.A.Frontiers in Neurology1664-22952025-04-011610.3389/fneur.2025.15092041509204Acupuncture as adjunctive therapy for acute cerebral infarction: a randomized clinical trialJiang-Peng Cao0Jiang-Peng Cao1Jiang-Peng Cao2Xin-Yue Du3Xiao-Xi Liu4Xiao-Xi Liu5Meng-Han Li6Meng-Han Li7Man Zhang8Sheng-Xuan Guo9Sheng-Xuan Guo10Qiu-Han Cai11Qiu-Han Cai12Jia-Xin Zhang13Jia-Xin Zhang14Jia-Xin Zhang15Shan-Shan Sun16Shan-Shan Sun17Shan-Shan Sun18Jia-Wei Han19Lin-Ling Chen20Na Zheng21Lan-Yu Jia22Gui-Ping Li23Gui-Ping Li24Yuan-Hao Du25Yuan-Hao Du26Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaNational Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, ChinaDepartment of Graduate School, Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaDepartment of Graduate School, Heilongjiang University of Chinese Medicine, Harbin, ChinaDepartment of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaNational Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, ChinaDepartment of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaNational Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, ChinaThe Second Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine, Hangzhou, ChinaDepartment of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaNational Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, ChinaDepartment of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaNational Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, ChinaDepartment of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaNational Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, ChinaDepartment of Graduate School, Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaDepartment of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaNational Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, ChinaDepartment of Graduate School, Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaFirst Hospital of Jilin University, Changchun, ChinaHuzhou Central Hospital, Huzhou, ChinaTianjin Huanhu Hospital, Tianjin, ChinaTianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, ChinaDepartment of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaNational Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, ChinaDepartment of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, ChinaNational Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, ChinaBackgroundAcute cerebral infarction (ACI) is the second leading cause of death and the major cause of disability worldwide, and there is an increasing interest in non-pharmacological treatments. Acupuncture has promising effects on ACI, but its efficacy and safety need to be verified through well-designed randomized clinical trials. We aimed to investigate the efficacy and safety of acupuncture as adjunctive therapy to improve neurological function in patients with ACI.MethodsThe multicenter, sham-controlled, patient- and assessor-blinded randomized controlled trial was conducted in 4 tertiary hospitals in China from January to September 2024. All participants received standard care as recommended by the guidelines and were randomly assigned (1:1:1) to manual acupuncture (MA), sham acupuncture (SA), or standard care (SC) only. Participants in the MA and SA groups received acupuncture treatment 6 times weekly for 2 weeks for a total of 12 sessions. The primary outcome was the change in the National Institutes of Health Stroke Scale score from baseline to 14 days. Safety outcomes included adverse events and serious adverse events.ResultsA total of 132 patients (median [IQR] age, 65 [58–69] years; 96 men [72.73%]), with a median (IQR) baseline National Institutes of Health Stroke Scale score of 11 (9–12) points, were included in the intention-to-treat analysis. Ten patients withdrew during the 14-day intervention, and another 7 patients withdrew during the 90-day follow-up. During the 14-day intervention, the median neurological impairment was significantly improved in the MA group compared to the SA group (4 [3, 5] vs. 3 [1.25, 4] points; Cohen’s d, 0.76; 95% CI, 0.33 to 1.19; p = 0.001). Adverse events occurred relatively equally between the MA and SA groups (19 [43.2%] vs. 13 [29.5%]; relative risk, 1.46; 95% CI, 0.83 to 2.58; p = 0.184).ConclusionTwelve sessions of MA were safe and effective in improving the neurological function of patients with ACI. The results of this trial indicate that MA can be recommended as a routine, supplemental therapy for improving neurological function in patients with ACI.Clinical trial registrationChiCTR2300079204 (Chinese Clinical Trial Registry, http://www.chictr.org.cn, registered on 27/12/2023).https://www.frontiersin.org/articles/10.3389/fneur.2025.1509204/fullacute cerebral infarctionacupunctureefficacysafetyrandomized controlled trial
spellingShingle Jiang-Peng Cao
Jiang-Peng Cao
Jiang-Peng Cao
Xin-Yue Du
Xiao-Xi Liu
Xiao-Xi Liu
Meng-Han Li
Meng-Han Li
Man Zhang
Sheng-Xuan Guo
Sheng-Xuan Guo
Qiu-Han Cai
Qiu-Han Cai
Jia-Xin Zhang
Jia-Xin Zhang
Jia-Xin Zhang
Shan-Shan Sun
Shan-Shan Sun
Shan-Shan Sun
Jia-Wei Han
Lin-Ling Chen
Na Zheng
Lan-Yu Jia
Gui-Ping Li
Gui-Ping Li
Yuan-Hao Du
Yuan-Hao Du
Acupuncture as adjunctive therapy for acute cerebral infarction: a randomized clinical trial
Frontiers in Neurology
acute cerebral infarction
acupuncture
efficacy
safety
randomized controlled trial
title Acupuncture as adjunctive therapy for acute cerebral infarction: a randomized clinical trial
title_full Acupuncture as adjunctive therapy for acute cerebral infarction: a randomized clinical trial
title_fullStr Acupuncture as adjunctive therapy for acute cerebral infarction: a randomized clinical trial
title_full_unstemmed Acupuncture as adjunctive therapy for acute cerebral infarction: a randomized clinical trial
title_short Acupuncture as adjunctive therapy for acute cerebral infarction: a randomized clinical trial
title_sort acupuncture as adjunctive therapy for acute cerebral infarction a randomized clinical trial
topic acute cerebral infarction
acupuncture
efficacy
safety
randomized controlled trial
url https://www.frontiersin.org/articles/10.3389/fneur.2025.1509204/full
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