PMID- 37351010
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230701
IS  - 1178-7074 (Print)
IS  - 1178-7074 (Electronic)
IS  - 1178-7074 (Linking)
VI  - 16
DP  - 2023
TI  - Effectiveness and Safety of Bu Shen Kai Qiao Fang in the Treatment of Alzheimer's 
      Disease: Study Protocol for a Multicenter, Prospective, Real-World Clinical 
      Trial.
PG  - 2573-2583
LID - 10.2147/IJGM.S418700 [doi]
AB  - BACKGROUND: Alzheimer's disease (AD) is a common degenerative disease of the 
      nervous system with serious impact on quality of life of patients and their 
      families. With an aging population, AD has become a major public health problem 
      in China and worldwide. However, the physiological and pathological mechanisms of 
      AD have not been fully elucidated, and there is a lack of effective prevention 
      and clinical treatment methods. Many studies have found that traditional Chinese 
      medicine (TCM) has a good therapeutic effect on cognitive function in AD 
      patients. Bu Shen Kai Qiao Fang (BSKQF) is one such Chinese herbal preparation 
      used in the treatment of AD. We designed a protocol for a real-world clinical 
      study of BSKQF combined with Donepezil hydrochloride (DH) to evaluate the 
      efficacy and safety of this approach in the treatment of AD patients. METHODS: 
      This is a protocol for a real-world, multicenter, prospective, observational 
      cohort study. The study will recruit 860 AD patients from four hospitals across 
      China. Equal numbers of patients will be treated with BSKQF and DH or with DH 
      only. The criteria for grouping are based primarily on patient preference. 
      Outcome measures include scores on the Mini-Mental State Examination (MMSE) and 
      Montreal Cognitive Assessment Scale (MOCA) and will be recorded at baseline, and 
      at one, two and three months after enrollment. The plasma Abeta42 and plasma Tau 
      levels of participating patients will also be measured by ELISA at baseline and 
      after 3 months of treatment. Safety metrics and adverse events (AEs) of 
      participating patients will be monitored and recorded. DISCUSSION: This study 
      will evaluate the clinical efficacy and safety of BSKQF in the treatment of AD. 
      The results will provide reliable evidence for the clinical application of BSKQF 
      in the treatment of AD. STUDY REGISTRATION: Trial registration: Chinese Clinical 
      Trial Registry, NO. ChiCTR2000039670, Registered 5 November 2020 
      https://www.chictr.org.cn/showprojEN.html?proj=63800.
CI  - (c) 2023 Xu et al.
FAU - Xu, ZeYu
AU  - Xu Z
AUID- ORCID: 0000-0001-9858-7628
AD  - Department of Brain and Mental Disease, Shanghai Municipal Hospital of 
      Traditional Chinese Medicine, Shanghai University of Traditional Chinese 
      Medicine, ShangHai, 200040, People's Republic of China.
FAU - Li, Ou
AU  - Li O
AUID- ORCID: 0000-0002-7179-849X
AD  - Department of Brain and Mental Disease, Shanghai Municipal Hospital of 
      Traditional Chinese Medicine, Shanghai University of Traditional Chinese 
      Medicine, ShangHai, 200040, People's Republic of China.
FAU - Liang, YaTing
AU  - Liang Y
AD  - Department of Brain and Mental Disease, Shanghai Municipal Hospital of 
      Traditional Chinese Medicine, Shanghai University of Traditional Chinese 
      Medicine, ShangHai, 200040, People's Republic of China.
FAU - Wu, ZhiBing
AU  - Wu Z
AD  - Department of Encephalopathy, The First Affiliated Hospital of Guangzhou 
      University of Chinese Medicine, Guangzhou, 510405, People's Republic of China.
FAU - Xu, Jiamei
AU  - Xu J
AD  - Department of Encephalopathy, The First Affiliated Hospital of Guangzhou 
      University of Chinese Medicine, Guangzhou, 510405, People's Republic of China.
FAU - Wang, Ling
AU  - Wang L
AD  - Department of Geriatrics, Shaanxi Provincial Hospital of Traditional Chinese 
      Medicine, Xi'an, 710003, People's Republic of China.
FAU - Li, Ling
AU  - Li L
AD  - Department of Geriatrics, Shaanxi Provincial Hospital of Traditional Chinese 
      Medicine, Xi'an, 710003, People's Republic of China.
FAU - Sun, YongNing
AU  - Sun Y
AD  - Department of Brain and Mental Disease, Shanghai Municipal Hospital of 
      Traditional Chinese Medicine, Shanghai University of Traditional Chinese 
      Medicine, ShangHai, 200040, People's Republic of China.
LA  - eng
PT  - Journal Article
DEP - 20230617
PL  - New Zealand
TA  - Int J Gen Med
JT  - International journal of general medicine
JID - 101515487
PMC - PMC10284162
OTO - NOTNLM
OT  - Alzheimer's disease
OT  - Abeta42
OT  - Bu Shen Kai Qiao Fang
OT  - MMSE
OT  - MOCA
OT  - real-world trial
OT  - tau
COIS- The authors declare that they have no conflicts of interest in this work.
EDAT- 2023/06/23 13:07
MHDA- 2023/06/23 13:08
PMCR- 2023/06/17
CRDT- 2023/06/23 10:27
PHST- 2023/04/25 00:00 [received]
PHST- 2023/06/09 00:00 [accepted]
PHST- 2023/06/23 13:08 [medline]
PHST- 2023/06/23 13:07 [pubmed]
PHST- 2023/06/23 10:27 [entrez]
PHST- 2023/06/17 00:00 [pmc-release]
AID - 418700 [pii]
AID - 10.2147/IJGM.S418700 [doi]
PST - epublish
SO  - Int J Gen Med. 2023 Jun 17;16:2573-2583. doi: 10.2147/IJGM.S418700. eCollection 
      2023.