国外近10年随机对照试验安慰针刺运用分析

Application of placebo acupuncture in randomized controlled trials in the past 10 years in foreign countries

系统回顾性分析近10年(2004—2014)安慰针在国外随机对照试验中的应用情况,总结安慰针设计方式,针对病种分析利弊,以探索较理想的安慰针对照设置。通过检索PubMed、EMBASE、OVID数据库,选择符合纳入标准的临床研究文献,分析针刺研究病种、安慰针设计、临床疗效方面。共纳入文献29篇,针刺研究病种以疼痛性疾病最多;安慰针设计应用较多的是套叠式可滑动钝头针,约占45.16%;选择部位多为非穴位点;针刺深度采用皮表非穿透性针刺比例较大,约60.00%,浅刺次之,约占26.67%;28篇表明针刺、安慰针临床疗效评价均有效,占96.55%,针刺优于及不优于安慰针各占37.93%。说明安慰针设计需综合疾病主要症状、可操作性、安全性、盲法实现、特异效应等多因素,在结局评价时尽可能选用客观观察指标。

The application of placebo acupuncture in randomized controlled trials in the past 10 years（2004-2014）in foreign countries was systematically reviewed to summarize the design of placebo acupuncture;according to category of diseases,advantages and disadvantages were analyzed to explore an ideal placebo acupuncture set.By retrieval in PubMed,EMBASE and OVID databases,the clinical study literature which met the inclusion criteria was searched,and the category of diseases,design of placebo acupuncture and clinical efficacy were analyzed.Totally 29 articles were included.The pain was the leading disease in category of diseases;the most commonly used application of placebo acupuncture design was telescopiform sliding blunt needle,accounting for 45.16%;the treatment locations were non-acupoints mostly;in the needling depth,approximately 60.00% selected non-penetrating needling and 26.67% selected superficial needling;28 articles indicated that acupuncture and placebo acupuncture had clinical effects,accounting for 96.55%;37.93% of articles indicated acupuncture was superior to placebo acupuncture and 37.93% of articles indicated acupuncture was not superior to placebo acupuncture.It is concluded that the design of placebo acupuncture should consider multiple factors,including main symptoms,operability,security,blinding and specific effects,and the objective indices should be selected for outcome evaluation.