Effect of acupuncture treatment on vascular cognitive impairment without dementia: study protocol for a randomized controlled trial.
BACKGROUND
Vascular cognitive impairment, no dementia (VCIND) is a condition at risk for future dementia and should be the target of preventive strategies. Preliminary evidence suggests that acupuncture may be a clinically effective intervention for people with early-stage vascular cognitive impairment. We will do a multicenter, 6-month, drug-controlled, nonblinded, randomized, parallel-group trial to determine whether acupuncture is effective for improving cognitive function and quality of life for patients with VCIND.


METHODS
A total of 216 eligible patients will be recruited and randomly assigned acupuncture for two sessions/week (n = 108) or citicoline 300 mg/day (n = 108) in a multicenter, 6-month trial. The primary endpoint is cognition (Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog)). Secondary endpoints include assessments of activities of daily living and behavioral symptoms (Clock Drawing Test (CDT), Activities of Daily Living (ADL) and Instrumental Activities of Daily Living scale (IADL)).


CONCLUSIONS
This will be the first large-scale trial specifically evaluating acupuncture therapy in VCIND. If the study confirms the effectiveness and safety of acupuncture treatment, it will be important to examine how the acupuncture approach could most effectively be integrated into the provision of routine healthcare.


BACKGROUND
This study is registered as an International Standard Randomised Controlled Trial on 17 January 2014, number ISRCTN 82980206.
Bo-Feng
BF
Yang
Xiang-Hong
XH
Zeng
Yan
Y
Liu
Qing-Nan
QN
Fu
Tian
T
He
Fang
F
Li
Guang-Xia
GX
Shi
Bao-Zhen
BZ
Liu
San-Feng
SF
Sun
Jun
J
Wang
Lei
L
Xiao
Yan-Mei
YM
Deng
Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 23 Meishuguanhou Street, Dongcheng District, Beijing 100010, China. lcz623780@126.com.
Cun-Zhi
CZ
Liu
D000203:Activities of Daily Living; D015670:Acupuncture Therapy; D000368:Aged; D000369:Aged, 80 and over; D002561:Cerebrovascular Disorders / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D002681:China; D002985:Clinical Protocols; D003071:Cognition; D003072:Cognition Disorders / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D005260:Female; D015577:Geriatric Assessment; D006801:Humans; D008297:Male; D008875:Middle Aged; D009483:Neuropsychological Tests; D011788:Quality of Life; D012107:Research Design; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome