外科安慰手术应用指南及其对针刺临床研究中假针刺应用的借鉴

ASPIRE guidelines and their enlightenment on application of sham acupuncture in clinical researches

合理、规范地应用假针刺对照是决定针刺临床研究质量的关键,亦是针刺临床研究面临的主要难题。英国国家健康研究所和医学研究委员会联合发表了随机化评价中外科安慰手术应用指南——ASPIRE指南,包括合理性与伦理、设计、实施、转化4个部分,为外科安慰手术的应用提供了全面的指导。同为操作性干预措施,针刺干预与外科手术有相似之处,故ASPIRE指南也可为假针刺对照的应用提供一定的指导。本文对ASPIRE指南进行了介绍,并结合假针刺对照研究的现状提出了其对假针刺对照应用的启示与借鉴。未来的研究应加强对假针刺对照合理性与伦理问题的考虑,规范地设计假针刺对照,并以合适的描述向患者传递假针刺相关的信息。

Reasonable and standard application of sham acupuncture control is the key to determine the quality of acupuncture clinical trials,and is also a difficult problem faced by acupuncture clinical research.The UK National Institute for Health Research and the Medical Research Council jointly published the Applying Surgical Placebo in Randomised Evaluation(ASPIRE)guidelines on the application of placebo surgical operation in randomized evaluation,which includes 4 parts:rationale and ethics,design,conduct,and interpretation and translation,providing comprehensive guidance for the application of placebo controls in surgical trials.As an operational intervention,acupuncture is similar to surgery,so,ASPIRE guidelines can also provide certain guidance for the application of sham acupuncture.In the present paper,we introduce the ASPIRE guidelines,and put forward its enlightenment and reference to the application of sham acupuncture control in combination with retrospecting the current situations of sham acupuncture research.We hold that future studies should strengthen the consideration of the rationality and ethics of sham acupuncture,standardize the design of sham acupuncture control,and convey the information related to sham acupuncture to patients with appropriate descriptions.