title: [Analysis of acute stroke trials conducted in mainland China in the past 17 years].
abstract: OBJECTIVE
  To evaluate the current status and trend of acute stroke randomized controlled trials (RCTs) in Mainland China.
  
  
  METHODS
  Acute stroke RCTs were retrieved from 8 databases published in Chinese or English language from January 1996 to May 2013. Those with transient ischemic attack (TIA) or traumatic hemorrhage were excluded. Methodological items were referred to the Cochrane Collaboration's tool for assessing risk of bias. The definitions of Wade were used to assess the outcome measures. The data were processed by SPSS 16.0. Data were summarized as frequency (and %) or median and interquartile range. Difference in proportions was assessed with χ(2) test.
  
  
  RESULTS
  A total of 13 493 RCTs were identified. The number of acute stroke RCTs increased by years, but only 52 multi-center RCTs were published. There were 13 multi-center placebo controlled drug trials. Among them, only 3 had a sample size of over 500 cases. In multi-center non-drug trials, only 3 used allocation concealment. The studied types of stroke included ischemic stroke (63.9%, 8623/13 493), intracerebral hemorrhage (30.8%, 4157/13 493) and subarachnoid hemorrhage (5.3%, 713/13 495). There were 61.5% (32/52) multi-center drug trials, including 65.6% (21/32) in Western drug treatment and 34.4% (11/32) in traditional Chinese medicine. There were 38.5% (20/52) non-drug trials including 8 physical therapy, 7 surgery and 5 acupuncture treatment. There were 2 multi-center placebo controlled drug trials and 2 multi-center non-drug trials used mortality/disability for assessing outcome measures over a follow-up period of 90 days or more.
  
  
  CONCLUSIONS
  In the past 17 years in mainland China, the number of acute stroke RCTs has increased dramatically, but the high-quality trials are scarce. The future acute stroke trials should pay more attention to true randomization, blinding and better patient outcome measures.
authors.affiliation: Department of Neurology, West China Hospital, Sichuan University, Chengdu 610041, China.
authors.forename: Sha
authors.initials: S
authors.lastname: He
authors.affiliation: Department of Neurology, West China Hospital, Sichuan University, Chengdu 610041, China. Email: wyplmh@hotmail.com.
authors.forename: Ming
authors.initials: M
authors.lastname: Liu
authors.affiliation: Department of Neurology, West China Hospital, Sichuan University, Chengdu 610041, China.
authors.forename: Quan-tao
authors.initials: QT
authors.lastname: Zeng
mesh_terms: D002681:China / Q000453:epidemiology; D006801:Humans; D016032:Randomized Controlled Trials as Topic; D020521:Stroke / Q000453:epidemiology*