Objective To assess the efficacy and safety of Zhiling decoction for vascular dementia. Methods The Specialized Register of the Cochrane Dementia and Cognitive Improvement Group was searched in Feb. 2004 using the term Zhiling. In addition, we handsearched 83 traditional Chinese medicine journals （1993 to 2004 ）. We included all randomized controlled trials（RCTs）of Zhiling decoction treating people with vascular dementia. We also evaluated the internal validity of the RCTs . If all included RCTs were of high quality and homogeneity, then the meta-analysis was conducted. Results Only one RCT was identified. The outcomes were listed as the followings ： ① The Hasegawa＇ s dementia scale scoring （ HDS ） scores of the patients in Zhiling decoction group were improved significantly from baseline after 8 weeks course of treatment and there was no significant difference in the control group. The HDS scores improvement was greater than control group（P 〈0.01 ）o ② The latency of P3 was shorter in both groups after treatment, and there was a significant treatment effect in Zhiling group （t = -52. 09, 95% CI -69.79 to -34.39, P 〈0. 000 01 ）. The amplitude of 173 increased in both groups after treatment, and there was a non-sigmficant treatment effect in Zhiling group for change from baseline （t =1.40, 95% CI -0.02 to 2.82, P =0.05）. ③ Brain electrical activity monitoring （BEAM） showed that benefits in those treated by Zhiling decoction were higher than those treated by Naofukang with OR9.90 （ 95% CI 3.34 to 29.38）. ④In the Zhiling group serum cholesterol （P 〈0.01 ） , serum triglyceride （P 〈0.01 ） and LPO（P 〉0. 01 ） decreased after treatment. There was an increase in the level of high density lipoprotein （HDL） and superoxide dismutase （SOD） in red blood cells compared with baseline for Zhiling groups （P 〈0.01 ）. ⑤ The cerebral blood flow decreased in both groups after treatment, and there was a significant treatment effect in favour of Zhiling （treatment effect t = -1.03, 95% CI -1.26 to -0.80, P 〈0. 00001 ）.⑥ No side effects on heart, liver or renal function were reported in Zhiling decoction group. Conclusions The currendy available evidence is insufficient to assess the potential efficacy for Zhiling decoction in the treatment of vascular dementia. Just one RCT concerning the management of Zhifing decoction versus Naofukang suggests that Zhiling decoction may be effective in treating vascular dementia. Further randomised, double-blind, placebo-controlled trials are urgendy needed .