Objective To assess the clinical efficacy of stroke unit (SU) of integrated traditional Chinese medicine and western medicine in the treatment of acute cerebral stroke. Methods Randomized or quasi-randomized controlled trials (RCTs or q-RCTs) were identified from CBM (1978-2009), CNKI (1994-2009), VIP (1989-2009), PubMed (1966-2009), MEDLINE (1978-2009), Scifinder (1998-2009), and The Cochrane Library (Issue 6, 2009), and relevant journals from Liaoning University of Traditional Chinese Medicine were also hand searched. Data were extracted and evaluated by two reviewers independently with a designed extraction form. RevMan5.0.23 software was used for data analyses. Results A total of 12 RCTs and q-RCTs involving 2 316 patients were included. Meta-analyses showed that, stroke unit of integrated traditional Chinese medicine and western medicine was superior to general medicine treatment (Plt;0.05) in case fatality rate one month after stroke (RR= 0.34, 95%CI 0.22 to 0.54), discharge NIHSS score (WMD= –1.01, 95%CI –1.52 to –0.51) and discharge OHS score (WMD= –0.48, 95%CI –0.78 to –0.18); and it was superior to SU of western medicine (Plt;0.05) in NIHSS score one week after stroke (WMD= –2.38, 95%CI –4.08 to –0.68), NIHSS score one month after stroke (WMD= –1.52, 95%CI –2.32 to –0.73) NIHSS score three months after stroke (WMD= –1.77, 95%CI –2.59 to –0.95), difference value of NIHSS score of hospital admission and discharge (WMD= –1.94, 95%CI –2.54 to –1.34), OHS score one month after stroke (WMD= –0.56, 95%CI –0.95 to –0.17) and OHS score three months after stroke (WMD= –1.05, 95%CI –1.44 to –0.66). Conclusion The current limited evidence shows that there is a significant difference between stroke unit of integrated traditional Chinese medicine and western medicine and general medicine treatment. Although there is no significant difference compared with SU of western medicine, it is superior in improving the functional impairment of nerve as well as disability of injury. More large-scale RCTs with high quality are required to verify the effect of stroke unit of integrated traditional Chinese medicine and western medicine in the treatment of acute cerebral stroke.