摘要
安慰灸对照的合理设置是严谨规范地验证艾灸疗法有效性和安全性的前提。梳理当前艾灸临床试验对照组安慰灸设计的现状,分析艾灸临床试验面临的盲法设置困难、安全防范措施不充分、安全性评价缺失等问题及安慰灸设置的必要性,认为安慰灸尚存在无法同时控制艾灸自身独特的理化效应、灸法形式多样化但规范化不足、民众对艾灸认知度较高容易识别出安慰灸等难点和挑战。从艾条灸、艾炷灸、隔物灸、温针灸、温灸器等不同类型安慰灸设计的方法入手,提出了控制艾绒燃烧的理化效应、替换施灸材料及控制艾绒燃烧程度三种安慰灸设计思路,以期提升艾灸临床试验设计的方法学质量,促进艾灸临床试验设计的规范性和科学性。
To verify the effect and safety of mobixustion rigorously,it is on the premise that the sham moxibustion is designed in a reasonable way.This paper summarized the current situation of sham moxibustion design in clinical trials by analyzing the problems in terms of blinding difficulty,insufficient safety precautions and lack of safety evaluation,and discussed the necessity of setting sham moxibustion.It is concluded that current sham moxibustion cannot control the unique physical and chemical effects of moxibustion,and the standardization is insufficiency regardless of the varied moxibustion forms.The high awareness of moxibustion among the public makes another difficulty and challenge to hide the sham moxibustion.Based on the different types of moxibustion,such as moxa stick moxibustion,cone moxibustion,indirect moxibustion,warming-needle moxibustion,and moxibustion with moxa burner,three methods have been proposed in the design of sham moxibustion,which are controlling the physical and chemical effect of burning moxa,changing the moxibustion materials,and controlling the burning degree of moxa,in order to improve the methodological quality of moxibustion clinical trials,and promote the standardization and scientificity of trial design.
作者
李旭豪
李金玲
杨继国
LI Xuhao;LI Jinling;YANG Jiguo(School of Acupuncture,Moxibustion and Tuina,Shandong University of Traditional Chinese Medicine,Jinan,250355)
出处
《中医杂志》
CSCD
北大核心
2022年第19期1834-1839,共6页
Journal of Traditional Chinese Medicine
基金
国家自然科学基金(82174491)。
关键词
安慰灸
艾灸
临床试验设计
对照组
placebo moxibustion
moxibustion
clinical trial design
control group
