Acupuncture as Adjunctive Therapy for Acute Cerebral Infarction: A Randomized Clinical Trial

Jiang-Peng Cao ¹ Xin-Yue Du ² Xiao-Xi Liu ¹ Menghan Li ¹ Man Zhang ³ Sheng-Xuan Guo ¹ CAI Qiuhan ¹ Jia-Xin Zhang ¹ Shan-Shan Sun ¹ Jia-Wei Han ⁴ Lin-Ling Chen ⁵ Na Zheng ⁶ Lan-Yu Jia ⁷ Guiping Li ¹ Yuan-Hao Du ^1*

• ¹ First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China
• ² Heilongjiang University of Chinese Medicine, Harbin, Heilongjiang Province, China
• ³ The Second Affiliated Hospital of Zhejiang University of traditional Chinese Medicine, Hangzhou, China
• ⁴ First Hospital of Jilin University, Changchun, China
• ⁵ Huzhou Central Hospital, Huzhou, China
• ⁶ Tianjin Huanhu Hospital, Tianjin, China
• ⁷ Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, China

Background: Acute cerebral infarction (ACI) is the second leading cause of death and the major cause of disability worldwide, and there is an increasing interest in nonpharmacological treatments.Acupuncture has promising effects on ACI, but the efficacy and safety need to be verified by welldesigned randomized clinical trials. We aimed to investigate the efficacy and safety of acupuncture as adjunctive therapy to improve the neurological function in patients with ACI.Methods: A multi-center, sham-controlled, patient-and assessor-blinded, randomized controlled trial was performed with 132 patients randomly assigned to manual acupuncture (MA), sham acupuncture (SA), or standard care (SC) group (1:1:1 allocation), receiving twelve sessions of MA at true acupuncture points plus standard care (SC), twelve sessions of SA at sham acupuncture points (1 cun lateral to true acupuncture points) plus SC, or SC alone over 2 weeks. 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.Results: A total of 132 patients (median [IQR] age, 65 [58-69] years; 96 males [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 withdrew during the 14-day intervention and another 7 during the 90-day follow-up. During 14-day intervention, the median neurological impairment was significant improved in the MA group compared with the SA group (4 [3, 5] vs 3 [1.25, 4] points;Cohen d, 0.76; 95% CI, 0.33 to 1.19; P = .001). Adverse events occurred relatively equally between the MA and SA group (19 [43.2%] vs 13 [29.5%]; relative risk, 1.46; 95% CI, 0.83 to 2.58; P = .184).Conclusions: Twelve sessions of MA was safe and effective in improving the neurological function of patients with ACI. Results of this trial indicating that MA can be recommended as routine, supplemental therapy for neurological function improvement in patients with ACI.Trial Registration: ChiCTR2300079204 (Chinese Clinical Trial Registry, http://www.chictr.org.cn, registered on 27/12/2023).