Tianzhi granule improves cognition and BPSD of vascular dementia: a randomized controlled trial

Autor: Jing Shi, Mingqing Wei, Jingnian Ni, Feng Sun, Li Sun, Junfu Wang, Tao Yu, Kai Wang, Peiyuan Lv, Yunfu Wang, Yulian Zhang, Xuguang Gao, Xuanzhao Gao, Benyan Luo, Shanping Mao, Baorong Zhang, Xiangyang Ren, Fengchun Yu, Wenli Hu, Ping Yin, Nanjin Wu, Xianfeng Liu, Qi Bi, Yongyan Wang, Jinzhou Tian, The CHASE Study Group
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: Journal of Translational Medicine, Vol 18, Iss 1, Pp 1-10 (2020)
Druh dokumentu: article
ISSN: 1479-5876
DOI: 10.1186/s12967-020-02232-z
Popis: Abstract Background and purpose Tianzhi granule (TZ) is usually used for patients with vascular dementia (VaD) in China. The aim was to assess the effect of TZ by a randomized clinical trial (RCT). Methods A 24-week RCT was conducted in 16 centres. Participants were grouped into TZ, donepezil or placebo. The co-primary outcomes were the Vascular Dementia Assessment Scale-cognitive subscale (VADAS-cog) and Clinician’s Interview-based Impression of Change-plus caregiver information (CIBIC-plus). Results A total of 543 patients with mild to moderate VaD were enrolled, of whom 242 took TZ granules, 241 took donepezil, and 60 took placebo. The least-squares mean changes from baseline and 95% CI were 6.20 (5.31, 7.09) (TZ group), 6.53 (5.63, 7.42) (donepezil group) and 3.47 (1.76, 5.19) (placebo group), both TZ and donepezil showed small but significantly improvement compared with placebo group. The percent of improvement on the global impression which was measured by CIBIC-plus was 73.71% in TZ and 58.18% in placebo, there was significant different between TZ and placebo group (P = 0.004). No significant differences were observed between TZ and donepezil. No significant differences of adverse events were found. Conclusions TZ and donepezil could bring symptomatic benefit for mild to moderate VaD. Trial registration The protocol had retrospectively registered at clinical trial.gov, Unique identifier: NCT02453932, date of registration: May 27, 2015; https://www.clinicaltrials.gov/ct2/show/NCT02453932?term=NCT02453932&rank=1
Databáze: Directory of Open Access Journals
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