Shihong Zhang1, Bo Wu1, Ming Liu2, Ning Li1, Xianrong Zeng1, Hua Liu1, Qingcheng Yang1, Zhao Han1, Ping Rao1, Dong Wang1. 1. From the Department of Neurology (S.Z., B.W., M.L.) and Department of Acupuncture and Moxibustion (N.L.), West China Hospital, State Key Laboratory of Biotherapy and Cancer Center, Sichuan University, Chengdu, Sichuan Province, China; Department of Neurology (X.Z.), the People's Hospital of Sichuan province, Chengdu, Sichuan Province, China; Department of Neurology (H.L.), the Second Clinical Medical College of North Sichuan Medical College and Nanchong Central Hospital, Nanchong, China; Department of Neurology (Q.Y.), the People's Hospital of Anyang City, Anyang, Henan Province, China; Department of Neurology (Z.H.), the first Affiliated Hospital of Wenzhou Medical College, Wenzhou, Zhejiang Province, China; Department of Neurology (P.R.), the First People's Hospital of Chengdu City, Chengdu, Sichuan Province, China; and the Department of Neurology (D.W.), the Third Affiliated Hospital of Neimenggu Medical College, Baotou, Neimenggu Autonomous Region, China. 2. From the Department of Neurology (S.Z., B.W., M.L.) and Department of Acupuncture and Moxibustion (N.L.), West China Hospital, State Key Laboratory of Biotherapy and Cancer Center, Sichuan University, Chengdu, Sichuan Province, China; Department of Neurology (X.Z.), the People's Hospital of Sichuan province, Chengdu, Sichuan Province, China; Department of Neurology (H.L.), the Second Clinical Medical College of North Sichuan Medical College and Nanchong Central Hospital, Nanchong, China; Department of Neurology (Q.Y.), the People's Hospital of Anyang City, Anyang, Henan Province, China; Department of Neurology (Z.H.), the first Affiliated Hospital of Wenzhou Medical College, Wenzhou, Zhejiang Province, China; Department of Neurology (P.R.), the First People's Hospital of Chengdu City, Chengdu, Sichuan Province, China; and the Department of Neurology (D.W.), the Third Affiliated Hospital of Neimenggu Medical College, Baotou, Neimenggu Autonomous Region, China. wyplmh@hotmail.com.
Abstract
BACKGROUND AND PURPOSE:Acupuncture is a frequently used complementary treatment for ischemic stroke in China but the evidence available from previous randomized trials is inconclusive. The objective of this study was to assess the efficacy and safety of acupuncture in a more robustly designed larger scale trial. METHODS: This is a multicenter, single-blinded, randomized controlled trial. Eight hundred sixty-two hospitalized patients with limb paralysis between 3 to 10 days after ischemic stroke onset were allocatedacupuncture plus standard care or standard care alone. The acupuncture was applied 5 times per week for 3 to 4 weeks. The primary outcomes were defined as follows: (1) death/disability according to Barthel index and (2) death/institutional care at 6 months. RESULTS: There was a tendency of fewer patients being dead or dependent in acupuncture group (80/385, 20.7%) than in control group (102/396, 25.8%) at 6 months (odds ratio, 0.75; 95% confidence interval, 0.54-1.05). The benefit was noted in subgroup receiving ≥10 sessions of acupuncture (odds ratio, 0.68; 95% confidence interval, 0.47-0.98). There was no statistical difference in death or institutional care between the 2 groups (odds ratio, 1.06; 95% confidence interval, 0.63-1.79). Severe adverse events occurred in 7.6% and 8.3% of patients in the 2 groups, respectively. CONCLUSIONS:Acupuncture seemed to be safe in the subacute phase of ischemic stroke. If the potential benefits observed are confirmed in future larger study, the health gain from wider use of the treatment could be substantial. CLINICAL TRIAL REGISTRATION: URL: http://www.chictr.org/en/. Unique identifier: ChiCTR-TRC-11001353.
RCT Entities:
BACKGROUND AND PURPOSE: Acupuncture is a frequently used complementary treatment for ischemic stroke in China but the evidence available from previous randomized trials is inconclusive. The objective of this study was to assess the efficacy and safety of acupuncture in a more robustly designed larger scale trial. METHODS: This is a multicenter, single-blinded, randomized controlled trial. Eight hundred sixty-two hospitalized patients with limb paralysis between 3 to 10 days after ischemic stroke onset were allocated acupuncture plus standard care or standard care alone. The acupuncture was applied 5 times per week for 3 to 4 weeks. The primary outcomes were defined as follows: (1) death/disability according to Barthel index and (2) death/institutional care at 6 months. RESULTS: There was a tendency of fewer patients being dead or dependent in acupuncture group (80/385, 20.7%) than in control group (102/396, 25.8%) at 6 months (odds ratio, 0.75; 95% confidence interval, 0.54-1.05). The benefit was noted in subgroup receiving ≥10 sessions of acupuncture (odds ratio, 0.68; 95% confidence interval, 0.47-0.98). There was no statistical difference in death or institutional care between the 2 groups (odds ratio, 1.06; 95% confidence interval, 0.63-1.79). Severe adverse events occurred in 7.6% and 8.3% of patients in the 2 groups, respectively. CONCLUSIONS: Acupuncture seemed to be safe in the subacute phase of ischemic stroke. If the potential benefits observed are confirmed in future larger study, the health gain from wider use of the treatment could be substantial. CLINICAL TRIAL REGISTRATION: URL: http://www.chictr.org/en/. Unique identifier: ChiCTR-TRC-11001353.