Chen Yueqi, Zhang Wenjing, Wu Huangan, Lao Lixing, Xu Jian, Xu Shifen
Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.
Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China.
Trials. 2019 Feb 11;20(1):117. doi: 10.1186/s13063-019-3212-z.
Mild cognitive impairment (MCI) is known as a transitional status between normal cognitive function and Alzheimer's disease (AD). Acupuncture and Chinese herbal medicines (CHMs) are considered to be beneficial to patients with cognitive impairment. However, it is still unknown whether the combination of the two therapies could optimize the therapeutic effect for MCI. This trial is aimed to evaluate the therapeutic effects of acupuncture and the herbal formula Yishen Granule (YSG) for elderly patients with MCI.
METHODS/DESIGN: This is a multi-sited, patient-blinded, randomized controlled trial (RCT). Two hundred and forty eligible patients will be randomly divided into four groups: A. acupuncture with YSG, B. acupuncture with placebo herbal medicine, C. sham acupuncture with YSG or D. sham acupuncture with placebo herbal medicine. Acupuncture treatment will be given twice a week for 8 weeks and then once a week for 4 weeks. The herbal treatment patients will be given granules daily for 12 weeks, 8 weeks of standard-dose followed by 4 weeks of mid-dose. The primary outcome is scored by the Montreal Cognitive Assessment (MoCA). The secondary outcomes will be scored by the Mini-Mental State Examination (MMSE) and event-related potential (ERP). All the assessments will be conducted at baseline, and at the eighth and 12th week after intervention starts. The follow-up assessments will be performed with the MoCA in the 12th, 24th, and 36th weeks after intervention ends. Intention-to-treat (ITT) analysis will be used in this RCT.
This RCT will provide us information on the effect of treating MCI patients with only acupuncture, herbal formula as well as the combination of both. The additive effect or synergistic effect of acupuncture and Chinese herbal formula will then be analyzed.
This trial is registered with ChiCTR-INR-17011569 on 5 June 2017, and has been approved by the Ethics Committee of Shanghai Municipal Hospital of Traditional Chinese Medicine (2017SHL-KY-05).
轻度认知障碍（MCI）被认为是正常认知功能与阿尔茨海默病（AD）之间的过渡状态。针灸和中药被认为对认知障碍患者有益。然而，两种疗法联合使用是否能优化MCI的治疗效果仍不清楚。本试验旨在评估针灸和中药益神颗粒（YSG）对老年MCI患者的治疗效果。
方法/设计：这是一项多中心、患者盲法、随机对照试验（RCT）。240名符合条件的患者将被随机分为四组：A. 针灸联合YSG；B. 针灸联合安慰剂中药；C. 假针灸联合YSG；或D. 假针灸联合安慰剂中药。针灸治疗每周进行两次，共8周，然后每周进行一次，共4周。接受中药治疗的患者将连续12周每日服用颗粒剂，前8周服用标准剂量，后4周服用中剂量。主要结局通过蒙特利尔认知评估量表（MoCA）评分。次要结局将通过简易精神状态检查表（MMSE）和事件相关电位（ERP）评分。所有评估将在基线时以及干预开始后的第8周和第12周进行。干预结束后的第12周、第24周和第36周将使用MoCA进行随访评估。本RCT将采用意向性分析（ITT）。
本RCT将为我们提供仅使用针灸、中药配方以及两者联合治疗MCI患者的效果信息。然后将分析针灸和中药配方的相加作用或协同作用。
本试验于2017年6月5日在Chinese Clinical Trial Registry（ChiCTR）注册，注册号为ChiCTR-INR-17011569，并已获得上海市中医医院伦理委员会批准（2017SHL-KY-05）。
