Jia Yujie, Zhang Xuezhu, Yu Jianchun, Han Jingxian, Yu Tao, Shi Jiangwei, Zhao Lan, Nie Kun
First Teaching Hospital of Tianjin University of Traditional ChineseMedicine, Tianjin, 300193, China.
BMC Complement Altern Med. 2017 Dec 29;17(1):556. doi: 10.1186/s12906-017-2064-x.
Alzheimer's disease (AD) is the most common cause of dementia. However, none of medical treatment can stop or reverse the underlying neurodegenerative of AD at present. Acupuncture has attracted more and more attention in recent years due to its efficacy and very few side effects. Lately, a systematic review has thought that the evidence on the effectiveness of acupuncture in improving the cognitive function of AD patients was not powerful enough. Therefore, the aim of this study is to explore the efficacy and safety of acupuncture in patients with mild to moderate AD.
This was a randomized, controlled, parallel-group, exploratory study with 4-week baseline (T0), 12-week treatment phase (T1) and 12-week follow-up period (T2). Patients with mild to moderate AD meeting the included criteria were randomly allocated into either acupuncture or donepezil hydrochloride groups. The acupuncture group(AG) was given acupuncture treatment three times per week and the donepezil hydrochloride group(DG) group was administered donepezil hydrochloride once daily (5 mg/day for the first 4 weeks and 10 mg/day thereafter). Primary efficacy was measured using Alzheimer's disease Assessment Scale-Cognitive (ADAS-cog) and Clinician's Interview-Based Impression of Change-Plus (CIBIC-Plus). The second outcomes were measured with 23-Item Alzheimer's disease Cooperative Study Activities of Daily Living Scales (ADAS-ADL) and Neuropsychiatric Index (NPI).
Of 87 participants enrolled in the study, 79 patients finished their treatment and follow-up processes. The ADAS-cog scores for AG group showed obvious decreases at T2 and ∆(T2-T0)when compared with DG group, and significant between-group differences were detected (all p < 0.05). The mean CIBIC-Plus values for the AG group at T1 and T2 were much lower than that for the DG group, and there were significant differences between the two groups (푃<0.05). There were no significant between-group differences in the scores of ADAS-ADL and NPI during the study period. Treatment discontinuations due to adverse events were 0 (0%) and 4 (9.09%) for the AG and DG groups, respectively.
Acupuncture is safe, well tolerated and effective in improving the cognitive function, global clinical status of AD.
ChiCTR-IOR-17010465 (Retroactively registered on 18 JAN 2017).
阿尔茨海默病（AD）是痴呆最常见的病因。然而，目前尚无任何药物治疗能够阻止或逆转AD潜在的神经退行性变。近年来，针灸因其疗效显著且副作用极少而越来越受到关注。最近，一项系统评价认为，针灸改善AD患者认知功能有效性的证据不够充分。因此，本研究旨在探讨针灸治疗轻至中度AD患者的疗效及安全性。
本研究为随机、对照、平行组探索性研究，包括4周基线期（T0）、12周治疗期（T1）和12周随访期（T2）。符合纳入标准的轻至中度AD患者被随机分为针灸组或盐酸多奈哌齐组。针灸组（AG）每周接受3次针灸治疗，盐酸多奈哌齐组（DG）每天服用1次盐酸多奈哌齐（前4周5mg/天，此后10mg/天）。主要疗效指标采用阿尔茨海默病认知评定量表（ADAS-cog）和临床医师基于访谈的变化印象加量表（CIBIC-Plus）进行评估。次要结局指标采用23项阿尔茨海默病合作研究日常生活能力量表（ADAS-ADL）和神经精神症状量表（NPI）进行评估。
本研究共纳入87例参与者，79例患者完成了治疗及随访过程。与DG组相比，AG组在T2时的ADAS-cog评分及∆（T2-T0）显著降低，两组间差异有统计学意义（均P<0.05）。AG组在T1和T2时的CIBIC-Plus平均分值均显著低于DG组，两组间差异有统计学意义（P<0.05）。研究期间，两组在ADAS-ADL和NPI评分方面差异无统计学意义。AG组和DG组因不良事件导致的治疗中断分别为0例（0%）和4例（9.09%）。
针灸治疗轻至中度AD安全、耐受性好，且能有效改善认知功能及整体临床状态。
ChiCTR-IOR-17010465（于2017年1月18日追溯注册）
