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. CONCLUSION: 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.
Subject(s)
Stroke/epidemiology , China/epidemiology , Humans , Randomized Controlled Trials as TopicABSTRACT
BACKGROUND AND PURPOSE: Distinguishing between symptoms of posterior circulation infarction (PCI) and anterior circulation infarction (ACI) can be challenging. This study evaluated the frequency of symptoms/signs in the 2 vascular territories to determine the diagnostic value of particular symptoms/signs for PCI. METHODS: Neurological deficits were reviewed and compared from 1174 consecutive patients with a diagnosis of PCI or ACI confirmed by magnetic resonance imaging in the Chengdu Stroke Registry. The diagnostic value of specific symptoms/signs for PCI was determined by measuring their sensitivity, specificity, positive predictive value (PPV), and the OR. RESULTS: Homolateral hemiplegia (PCI, 53.6% versus ACI, 74.9%; P<0.001), central facial/lingual palsy (PCI, 40.7% versus ACI, 62.2%; P<0.001), and hemisensory deficits (PCI, 36.4% versus ACI, 34.2%; P=0.479) were the 3 most common symptoms/signs in PCI and ACI. The signs with the highest predictive values favoring a diagnosis of PCI were Horner's syndrome (4.0% versus 0%; P<0.001; PPV=100.0%; OR=4.00), crossed sensory deficits (3.0% versus 0%; P<0.001; PPV=100.0%; OR=3.98), quadrantanopia (1.3% versus 0%; P<0.001; PPV=100.0%; OR=3.93), oculomotor nerve palsy (4.0% versus 0%; P<0.001; PPV=100.0%; OR=4.00), and crossed motor deficits (4.0% versus 0.1%; P<0.001; PPV=92.3%; OR=36.04); however, all had a very low sensitivity, ranging from 1.3% to 4.0%. CONCLUSIONS: This study indicates that the symptoms/signs considered typical of PCI occur far less often than was expected. Inaccurate localization would occur commonly if clinicians relied on the clinical neurological deficits alone to differentiate PCI from ACI. Neuroimaging is vital to ensure accurate localization of cerebral infarction.
