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Tianzhi granule improves cognition and BPSD of vascular dementia: a randomized controlled trial
- Source :
- Journal of Translational Medicine, Vol 18, Iss 1, Pp 1-10 (2020), Journal of Translational Medicine
- Publication Year :
- 2020
- Publisher :
- BMC, 2020.
-
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
- Subjects :
- medicine.medical_specialty
China
lcsh:Medicine
Placebo
Placebo group
Vascular dementia
General Biochemistry, Genetics and Molecular Biology
law.invention
03 medical and health sciences
0302 clinical medicine
Cognition
Randomized controlled trial
Double-Blind Method
Piperidines
law
Alzheimer Disease
Internal medicine
mental disorders
medicine
Humans
030212 general & internal medicine
Adverse effect
Trial registration
Donepezil
business.industry
Dementia, Vascular
Research
Tianzhi granule
lcsh:R
General Medicine
medicine.disease
Treatment Outcome
Indans
Behavioral and psychological symptoms of dementia
Herbal medicine
business
030217 neurology & neurosurgery
medicine.drug
Subjects
Details
- Language :
- English
- ISSN :
- 14795876 and 02453932
- Volume :
- 18
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- Journal of Translational Medicine
- Accession number :
- edsair.doi.dedup.....53814c8ca26af0f34c2e32ba6e66bc77