OBJECTIVE: To evaluate the efficacy and safety of Danqipiantan capsule (DPC) for the treatment of stroke. METHODS: PubMed, China Science And Technology Journal Database, Wanfang Database, Chinese periodicals in the China National Knowledge Infrastructure, and the General Hospital of Tianjin Medical University's Library were searched until July 2012. Randomized controlled trials (RCTs) and observational studies that reported the use of DPC for treatment of stroke were selected. RESULTS: Eleven

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... ticles that included 12 RCTs, and 2 articles that included 3 observational studies were identified. A total of 2590 patients participated in the studies. We found that there was a signifi-cant statistical difference between DPC treatment groups and the control groups in terms of the effective rate [risk ratio (RR), 1.14; 95% confidence intervals (CI), 1.04, 1.25; P=0.01], Fugl-Meyer Assessment Scale [weighted mean difference (WMD), 9.77; 95% CI (4.84, 14.70); P=0.00], Barthel Index [WMD=6.40; 95% CI (3.15, 9.65)], and mean flow velocity [WMD= 5.79; 95% CI (1.64, 9.94)]. There were no significant differences for The National Institutes of Health Stroke Scale [WMD=0.60; 95% CI (-1.09, 2.29)], visual field defects [left visual field: WMD=-203.10; 95% CI (-424.41, 18.21); right visual field: WMD=-172.60; 95% CI ( -409.29, 64.09)] or the functional independence measure [WMD=-7.90; 95% CI ( -16.64, 0.84)]. Seven articles that included eight RCTs reported the safety of DPC treatment. Two articles that included three observational studies also reported beneficial effects for DPC. Because the Chinese studies were of poor methodological quality, and most of the sample sizes were small, our analysis was likely affected by bias. CONCLUSION: DPC has a beneficial effect and is relatively safe when used for the treatment of stroke.