Efficacy and safety of the compound Chinese medicine SaiLuoTong in vascular dementia: A randomized clinical trial.

INTRODUCTION: No licensed medications are available to treat vascular dementia (VaD). METHODS: Patients were randomly assigned to experimental groups (SaiLuoTong [SLT] 360 or 240 mg for groups A and B for 52 weeks, respectively) or placebo group (SLT 360 mg and 240 mg for group C only from weeks 27 to 52, respectively). RESULTS: Three hundred twenty-five patients were included in final analysis. At week 26, the difference in VaD Assessment Scale-cognitive subscale scores was 2.67 (95% confidence interval, 1.54 to 3.81) for groups A versus C, and 2.48 (1.34 to 3.62) for groups B versus C (both P < .0001). However, at week 52, no difference was observed among the groups on the VaD Assessment Scale-cognitive subscale (P = .062) because of the emerging efficacy of SLT in placebo beginning at week 27. DISCUSSION: This study suggests that SLT is effective for treatment of VaD, and this compound Chinese medicine may represent a better choice to treat VaD.