Yang et al. Trials 2014, 15:442 http://www.trialsjournal.com/content/15/1/442
TRIALS
STUDY PROTOCOL
Open Access
Effect of acupuncture treatment on vascular cognitive impairment without dementia: study protocol for a randomized controlled trial Bo-Feng Yang1,2, Xiang-Hong Zeng1, Yan Liu1, Qing-Nan Fu1, Tian He1, Fang Li1, Guang-Xia Shi1, Bao-Zhen Liu3, San-Feng Sun3, Jun Wang4, Lei Xiao5, Yan-Mei Deng5 and Cun-Zhi Liu1*
Abstract 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/Design: 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)). Discussion: 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. Trial registration: This study is registered as an International Standard Randomised Controlled Trial on 17 January 2014, number ISRCTN 82980206.
Background Cerebrovascular disease is the second most common cause of cognitive disorders [1]. Vascular cognitive impairment (VCI) reflects cognitive disorders that are associated with vascular disease [2]. Some stroke-related factors such as multiple small or large strokes and ischaemic whitematter lesions have been associated with poststroke VCI. Six months after stroke, as many as 44 to 74% of patients present some degree of cognitive disturbance [3-5]. Stroke patients with cognitive impairment but no dementia have an increase in the 5-year risk of developing dementia of any type [6]. VCI with no dementia (VCIND) is a potentially treatable and preventable cause of dementia in later * Correspondence: [email protected] 1 Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 23 Meishuguanhou Street, Dongcheng District, Beijing 100010, China Full list of author information is available at the end of the article
life, and familiarity with this condition will help the practitioner provide better care to patients [1]. Acupuncture is widely used for patients with cognitive disorders. It has been confirmed that acupuncture has positive effect on cognition and quality of life in patients who had a stroke [7]. However, there is no data on the effectiveness and safety of acupuncture used for VCIND patients. The aim of this study is to assess the effectiveness and safety of acupuncture in the treatment of VCIND patients.
Methods/Design Design
The design is a three-center randomized trial (Figure 1). Two hundred and sixteen patients with VCIND will be recruited for inclusion in the study upon fulfillment of the selection criteria. The patients will be randomly allocated into the acupuncture treatment group (two sessions/week for 3 months) or the citicoline (Qilu Pharmaceutical Co.,
© 2014 Yang et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Yang et al. Trials 2014, 15:442 http://www.trialsjournal.com/content/15/1/442
Page 2 of 5
Figure 1 Flow chart.
Ltd., Shandong, China) control group (100 mg/time, three times/day for 3 months). There will be a 3-month followup period. General ethical approval has been obtained from the ethics committee of the Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University on 22 March, 2013 (Ref: 201317) (Additional file 1). Participants
Patients will be recruited in acupuncture clinics in the Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, the Beijing Chinese Medicine Hospital in Huairou District, the Beijing Fengtai Hospital of Integrative Medicine and the Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine. Inclusion criteria
Patients who meet all of the following conditions will be considered for enrollment. The inclusion criteria are as follows: subjects (males and females) age 55 to 85 years
old; fluency in language sufficient to reliably complete all study assessments; a Hachinski score ≥7; evidence of vascular lesions based on neuroradiology; a Mini-Mental State Examination (MMSE) score > dementia threshold corrected according to the years of education (score >17, score >20 and score >24 for 0, ≤6, and >6 years of education, respectively); a Montreal Cognitive Assessment (MoCA) score
TRIALS
STUDY PROTOCOL
Open Access
Effect of acupuncture treatment on vascular cognitive impairment without dementia: study protocol for a randomized controlled trial Bo-Feng Yang1,2, Xiang-Hong Zeng1, Yan Liu1, Qing-Nan Fu1, Tian He1, Fang Li1, Guang-Xia Shi1, Bao-Zhen Liu3, San-Feng Sun3, Jun Wang4, Lei Xiao5, Yan-Mei Deng5 and Cun-Zhi Liu1*
Abstract 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/Design: 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)). Discussion: 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. Trial registration: This study is registered as an International Standard Randomised Controlled Trial on 17 January 2014, number ISRCTN 82980206.
Background Cerebrovascular disease is the second most common cause of cognitive disorders [1]. Vascular cognitive impairment (VCI) reflects cognitive disorders that are associated with vascular disease [2]. Some stroke-related factors such as multiple small or large strokes and ischaemic whitematter lesions have been associated with poststroke VCI. Six months after stroke, as many as 44 to 74% of patients present some degree of cognitive disturbance [3-5]. Stroke patients with cognitive impairment but no dementia have an increase in the 5-year risk of developing dementia of any type [6]. VCI with no dementia (VCIND) is a potentially treatable and preventable cause of dementia in later * Correspondence: [email protected] 1 Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 23 Meishuguanhou Street, Dongcheng District, Beijing 100010, China Full list of author information is available at the end of the article
life, and familiarity with this condition will help the practitioner provide better care to patients [1]. Acupuncture is widely used for patients with cognitive disorders. It has been confirmed that acupuncture has positive effect on cognition and quality of life in patients who had a stroke [7]. However, there is no data on the effectiveness and safety of acupuncture used for VCIND patients. The aim of this study is to assess the effectiveness and safety of acupuncture in the treatment of VCIND patients.
Methods/Design Design
The design is a three-center randomized trial (Figure 1). Two hundred and sixteen patients with VCIND will be recruited for inclusion in the study upon fulfillment of the selection criteria. The patients will be randomly allocated into the acupuncture treatment group (two sessions/week for 3 months) or the citicoline (Qilu Pharmaceutical Co.,
© 2014 Yang et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Yang et al. Trials 2014, 15:442 http://www.trialsjournal.com/content/15/1/442
Page 2 of 5
Figure 1 Flow chart.
Ltd., Shandong, China) control group (100 mg/time, three times/day for 3 months). There will be a 3-month followup period. General ethical approval has been obtained from the ethics committee of the Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University on 22 March, 2013 (Ref: 201317) (Additional file 1). Participants
Patients will be recruited in acupuncture clinics in the Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, the Beijing Chinese Medicine Hospital in Huairou District, the Beijing Fengtai Hospital of Integrative Medicine and the Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine. Inclusion criteria
Patients who meet all of the following conditions will be considered for enrollment. The inclusion criteria are as follows: subjects (males and females) age 55 to 85 years
old; fluency in language sufficient to reliably complete all study assessments; a Hachinski score ≥7; evidence of vascular lesions based on neuroradiology; a Mini-Mental State Examination (MMSE) score > dementia threshold corrected according to the years of education (score >17, score >20 and score >24 for 0, ≤6, and >6 years of education, respectively); a Montreal Cognitive Assessment (MoCA) score
