■通过荟萃分析系统评估针灸治疗阿尔茨海默病(AD)认知障碍的疗效,以期为针刺疗法在AD临床过程中的应用提供循证证据。
■从数据库建立到2022年12月31日,中国生物医学文献数据库(CBM),中国国家知识网(CNKI),VIP数据库,万方数据库,Pubmed,系统检索了Embase和Cochrane图书馆数据库。收集已发表的针灸治疗AD认知障碍的随机对照临床试验(RCTS)。干预组给予单纯针刺或联合其他治疗,与对照组相同;对照组给予西医常规治疗。研究的主要结局指标为受试者的认知功能评估,包括:简单精神状态检查量表(MMSE),日常生活能力量表(ADL)评估,阿尔茨海默病认知功能评估量表(ADAS-Cog),中医证候积分(SDSD),蒙特利尔认知测验(MoCA),次要结局指标为不良反应发生情况。文学筛选,数据提取,纳入文献的质量评价由两名研究人员独立进行,根据Cochrane手册中推荐的偏倚风险评估工具。数据采用RevMan5.3软件进行分析。二分变量由风险比(OR)和95%CI表示,连续性变量由平均差异(MD)和95%CI表示。对于异质性分析,当P>0.1且I2≤50%时,应用固定效应模型。当P≤0.1且I2>50%时,应用随机效应模型。
■共有1,172名符合条件的受试者被纳入18个RCTS,干预组595例,对照组577例。meta分析结果如下:针刺干预组改善MMSE[MD=1.67,95%CI(0.94,2.41),P<0.00001],ADL[MD=-1.18,95%CI(-3.09,0.72),P=0.22],ADAS-Cog[MD=3.31,95%CI(5.84,0.78),P=0.01],SDSD[MD=2.40,95%CI(3.53,1.26),P<0.0001],MoCA[MD=4.80,95%CI(3.74,5.86),P=0.04]均优于对照组。干预组未出现与针刺相关的严重不良反应,不良反应发生率和严重程度均低于对照组,具有统计学意义[OR=0.17,95%CI(0.04,0.67),P=0.01]。
■现有数据表明,针灸疗法在改善阿尔茨海默病患者的认知功能障碍和提高自理能力方面具有一定的优势。然而,由于RCTS的数量和评估针灸疗效的病例较少,以及纳入研究中测量偏差和选择性偏差的可能性,它仍然无法对其有效性进行高强度的演示。进一步大规模,高质量随机,需要双盲对照试验来评估其疗效.
■https://inplasy.com/inplasy-2021-12-0125/,标识符:INPLASY2021120125。
UNASSIGNED: To systematically evaluate the efficacy of acupuncture in the treatment of cognitive impairment in Alzheimer\'s disease (AD) by meta-analysis, in order to provide evidence-based evidence for the application of acupuncture therapy in the clinical process of AD.
UNASSIGNED: From the establishment of the database to December 31, 2022, China Biomedical Literature Database (CBM), China National Knowledge Network (CNKI), VIP database, WanFang Database, Pubmed, Embase and Cochrane Library Database were systematically searched. To collect published randomized controlled clinical trials (RCTS) of acupuncture in the treatment of cognitive impairment in AD. The subjects in the intervention group were given acupuncture alone or combined with other treatments the same as the control group; the control group received conventional Western medicine treatment. The main outcome indicators of the study were cognitive function assessment of subjects, including: Simple Mental State Examination Scale (MMSE), Assessment of daily Living Ability Scale (ADL), Alzheimer\'s Disease Cognitive Function Assessment Scale (ADAS-Cog), TCM syndrome score (SDSD), Montreal Cognitive Test (MoCA), Secondary outcome indicators were the occurrence of adverse reactions. Literature screening, data extraction, and quality evaluation of the included literature were performed independently by two researchers, according to bias risk assessment tools recommended in the Cochrane manual. Data were analyzed by RevMan5.3 software. Dichotomous variables were represented by risk ratio (OR) and 95% CI, and continuity variables were represented by mean difference (MD) and 95% CI. For heterogeneity analysis, when P > 0.1 and I 2 ≤ 50%, fixed effect model was applied. When P ≤ 0.1 and I 2 > 50%, the random effects model is applied.
UNASSIGNED: A total of 1,172 eligible subjects were included in 18 RCTS, including 595 in the intervention group and 577 in the control group. The results of meta-analysis are as follows: acupuncture intervention group improved MMSE [MD = 1.67, 95% CI (0.94, 2.41), P < 0.00001], ADL [MD = -1.18, 95% CI (-3.09, 0.72), P = 0.22], ADAS-Cog [MD = 3.31, 95% CI (5.84, 0.78), P = 0.01], SDSD [MD = 2.40, 95% CI (3.53, 1.26), P < 0.0001], MoCA [MD = 4.80, 95% CI (3.74, 5.86), P = 0.04] were better than the control group. No serious adverse reactions related to acupuncture were observed in the intervention group, and the incidence and severity of adverse reactions were lower than those in the control group, with statistical significance [OR = 0.17, 95% CI (0.04, 0.67), P = 0.01].
UNASSIGNED: Existing data show that acupuncture therapy has certain advantages in improving cognitive dysfunction and improving self-care ability of patients with Alzheimer\'s disease. However, due to the small number of RCTS and cases evaluating the efficacy of acupuncture, and the possibility of measurement bias and selectivity bias in included studies, it is still unable to conduct high-intensity demonstration on its effectiveness. Further large-scale, high-quality randomized, double-blind controlled trials are needed to evaluate its efficacy.
UNASSIGNED: https://inplasy.com/inplasy-2021-12-0125/, identifier: INPLASY2021120125.