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

Jianping Jia; Cuibai Wei; Shuoqi Chen; Fangyu Li; Yi Tang; Wei Qin; Lu Shi; Min Gong; Hui Xu; Fang Li; Jia He; Haiqing Song; Shanshan Yang; Aihong Zhou; Fen Wang; Xiumei Zuo; Changbiao Chu; Junhua Liang; Longfei Jia; Serge Gauthier

doi:10.1016/j.trci.2018.02.004

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

Alzheimers Dement (N Y). 2018 Mar 22:4:108-117. doi: 10.1016/j.trci.2018.02.004. eCollection 2018.

Authors

Jianping Jia^{1

2

3

4

5}, Cuibai Wei¹, Shuoqi Chen¹, Fangyu Li¹, Yi Tang¹, Wei Qin¹, Lu Shi¹, Min Gong¹, Hui Xu¹, Fang Li⁶, Jia He⁷, Haiqing Song¹, Shanshan Yang⁸, Aihong Zhou¹, Fen Wang¹, Xiumei Zuo¹, Changbiao Chu¹, Junhua Liang¹, Longfei Jia⁹, Serge Gauthier¹⁰

Affiliations

¹ Innovation Center for Neurological Disorders, Department of Neurology, Xuan Wu Hospital, Capital Medical University, Beijing, China.
² Beijing Key Laboratory of Geriatric Cognitive Disorders, Beijing, China.
³ Center of Alzheimer's Disease, Beijing Institute for Brain Disorders, Beijing, China.
⁴ Key Laboratory of Neurodegenerative Diseases, Ministry of Education, Beijing, China.
⁵ National Clinical Research Center for Geriatric Disorders, Beijing, China.
⁶ Department of Gerontology, Fuxing Hospital, Capital Medical University, Beijing, China.
⁷ Department of Health Statistics, Second Military Medical University, Shanghai, China.
⁸ Department of Neurology, Daqing Oilfield General Hospital, China.
⁹ Department of Neurology, Henry Ford Hospital, Detroit, MI, USA.
¹⁰ Centre for Studies in Aging, McGill University, Montreal, QC, Canada.

Abstract

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.

Keywords: Clinical trial; Compound Chinese medicine; SaiLuoTong/SLT; Vascular dementia.