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Acupuncture as adjunctive therapy for acute cerebral infarction: a randomized clinical trial
Jiang-Peng Cao1,2,3, Xin-Yue Du4, Xiao-Xi Liu1,2
1Department of Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, 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 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.
Methods:
The 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.
Results:
A 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).
Conclusion:
Twelve 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 Registration:
ChiCTR2300079204 (Chinese Clinical Trial Registry, http://www.chictr.org.cn, registered on 27/12/2023).
