title: Cognitive Improvement during Treatment for Mild Alzheimer's Disease with a Chinese Herbal Formula: A Randomized Controlled Trial.
abstract: OBJECTIVE
  To explore the efficacy of Chinese herbal formula compared with donepezil 5 mg/day in patients with mild Alzheimer's disease (AD).
  
  
  METHODS
  Patients with mild AD meeting the criteria were randomized into Chinese herbal formula Yishen Huazhuo decoction (YHD) group and donepezil hydrochloride (DH) group during the 24-week trial. The outcomes were measured by ADAS-cog, MMSE, ADL, and NPI with linear mixed-effect models.
  
  
  RESULTS
  144 patients were randomized. The mean scores of ADAS-cog and MMSE in both YHD group and DH group both improved at the end of the 24-week treatment period. The results also revealed that YHD was better at improving the mean scores of ADAS-cog and MMSE than DH. Linear mixed-effect models with repeated measures showed statistical significance in time × group interaction effect of ADAS-cog and also in time × group interaction effect of MMSE. The data showed YHD was superior to DH in improving the scores and long term efficacy.
  
  
  CONCLUSIONS
  Our study suggests that Chinese herbal formula YHD is beneficial and effective for cognitive improvement in patients with mild AD and the mechanism might be through reducing amyloid-β (Aβ) plaque deposition in the hippocampus.
  
  
  BACKGROUND
  Chinese Clinical Trial Registry ChiCTR-TRC-12002846.
authors.affiliation: Department of Acupuncture and Cerebropathy, Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Yulian
authors.initials: Y
authors.lastname: Zhang
authors.affiliation: Department of Acupuncture and Cerebropathy, Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Cuiru
authors.initials: C
authors.lastname: Lin
authors.affiliation: Department of Geriatric, Longhua Hospital of Shanghai University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Linlin
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Department of Acupuncture and Cerebropathy, Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Yuanwu
authors.initials: Y
authors.lastname: Cui
authors.affiliation: Department of Geriatric, Longhua Hospital of Shanghai University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Yun
authors.initials: Y
authors.lastname: Gu
authors.affiliation: Department of Acupuncture and Cerebropathy, Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Jiakui
authors.initials: J
authors.lastname: Guo
authors.affiliation: Department of Traditional Chinese Medicine, Tianjin Huanhu Hospital, Tianjin, China.
authors.forename: Di
authors.initials: D
authors.lastname: Wu
authors.affiliation: Graduate Institutes, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Li
authors.affiliation: Department of Acupuncture and Cerebropathy, Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.
authors.forename: Wanshan
authors.initials: W
authors.lastname: Song
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000544:Alzheimer Disease / Q000188:drug therapy*; D016229:Amyloid beta-Peptides / Q000378:metabolism; D002681:China; D003071:Cognition / Q000187:drug effects*; D000077265:Donepezil; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007189:Indans / Q000627:therapeutic use*; D008297:Male; D008609:Mental Status Schedule; D008875:Middle Aged; D010880:Piperidines / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D016229:Amyloid beta-Peptides; D004365:Drugs, Chinese Herbal; D007189:Indans; D010880:Piperidines; C526709:yishen huoxue decoction; D000077265:Donepezil