Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine, DongShin University, Naju City, 58245, Republic of Korea.
Clinical Research Center, DongShin University Gwangju Korean Medicine Hospital, 141, Wolsan-ro, Nam-gu, Gwangju City, 61619, Republic of Korea.
Trials. 2019 Sep 4;20(1):551. doi: 10.1186/s13063-019-3670-3.
BACKGROUND: Mild cognitive impairment (MCI) is an intermediate state between normal aging and Alzheimer's disease, which is the world's most common form of dementia. It is important to identify early and easily available interventions to delay the progression of MCI to Alzheimer's disease. Acupuncture has been reported to improve the clinical outcomes of MCI treatment. Acupuncture is a complex intervention, involving both specific and non-specific factors associated with therapeutic benefits. Therefore, we intend to obtain basic data for developing an optimal acupuncture treatment for MCI by comparing the effects of different acupuncture treatment methods on cognitive function in MCI patients. METHODS: This study will be a prospective, outcome-assessor-blinded, parallel-arm, single-center (DongShin University Gwangju Korean Medicine Hospital, Republic of Korea), randomized controlled clinical trial. Thirty-two participants with MCI will be randomized in equal numbers to four groups (basic acupuncture (BA), acupoint specificity (AS), needle duration (ND), or electroacupuncture (EA)) and receive acupuncture treatment once per day, 3 days/week for 8 weeks. The BA and ND groups will receive acupuncture treatment for 30 and 20 min, respectively, at Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20), and Shenting (GV24). The EA group will receive electroacupuncture treatment at the same acupoints for 30 min. The AS group will receive acupuncture treatment at GV20, EX-HN1, GB20, GV24, and Taixi (KI3) for 30 min. The outcome measured will be scores on the Korean version of the Alzheimer's Disease Assessment Scale-cognitive subscale, the Korean version of the Montreal Cognitive Assessment, the Center for Epidemiological Studies Depression scale, the Korean Activities of Daily Living scale, the Korean Instrumental Activities of Daily Living scale, and the European Quality of Life Five Dimension Five Level scale. All scores will be recorded before intervention, 8 weeks after the first intervention, and 12 weeks after completing the intervention. DISCUSSION: Four acupuncture protocols will be assessed and compared as potential MCI treatments. This study is expected to provide data to be used in developing an optimal acupuncture method for MCI treatment. TRIAL REGISTRATION: Clinical Research Information Service, KCT0003430 . Registered on 16 January 2019. http://cris.nih.go.kr ).
背景:轻度认知障碍(MCI)是正常衰老与阿尔茨海默病之间的中间状态,是世界上最常见的痴呆症形式。识别早期和易于获得的干预措施以延缓 MCI 向阿尔茨海默病的进展非常重要。据报道,针刺可以改善 MCI 治疗的临床结局。针刺是一种复杂的干预措施,涉及与治疗益处相关的特异性和非特异性因素。因此,我们打算通过比较不同针刺治疗方法对 MCI 患者认知功能的影响,为开发针对 MCI 的最佳针刺治疗方法获得基础数据。
方法:这是一项前瞻性、结局评估者设盲、平行臂、单中心(韩国光州东新大学韩医院)、随机对照临床试验。32 名 MCI 患者将被随机分为四组(基础针刺组(BA)、穴位特异性组(AS)、针持续时间组(ND)或电针组(EA)),并接受每日 1 次、每周 3 次、共 8 周的针刺治疗。BA 和 ND 组分别接受 30 分钟和 20 分钟的针刺治疗,穴位为百会(GV20)、四神聪(EX-HN1)、风池(GB20)和神庭(GV24)。EA 组将接受 30 分钟电针治疗。AS 组将接受 GV20、EX-HN1、GB20、GV24 和太溪(KI3)的针刺治疗,时间为 30 分钟。测量的结果将是阿尔茨海默病评估量表认知子量表、蒙特利尔认知评估量表韩国版、流行病学研究抑郁量表、韩国日常生活活动量表、韩国工具性日常生活活动量表和欧洲生活质量五维五分量表的评分。所有评分将在干预前、第一次干预后 8 周和干预完成后 12 周记录。
讨论:将评估和比较四种针刺方案作为潜在的 MCI 治疗方法。这项研究有望提供数据,用于开发针对 MCI 治疗的最佳针刺方法。
试验注册:临床研究信息服务,KCT0003430。注册于 2019 年 1 月 16 日。http://cris.nih.go.kr)。
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