This study examined the application of the Rumsfeld Matrix to acupuncture clinical trials,particularly those published in leading medical journals such as The Journal of the American Medical Association(JAMA),British ...This study examined the application of the Rumsfeld Matrix to acupuncture clinical trials,particularly those published in leading medical journals such as The Journal of the American Medical Association(JAMA),British Medical Journal(BMJ),The Lancet,and The New Eng-land Journal of Medicine(NEJM).The integration of randomized clinical trials(RCTs)has in-troduced a level of academic rigor to acupuncture research,challenging the classical deter-ministic model and revealing a complex landscape of known knowns,known unknowns,un-known knowns,and unknown unknowns.While RCTs have validated acupuncture’s efficacy in certain conditions,they have also highlighted considerable challenges,including the limi-tations of control group designs and the potential influence of placebo effects.The recurring issue of no significant differences between real and sham acupuncture in many studies un-derscores the need for refined control strategies and a more nuanced understanding of acupuncture’s mechanisms.This investigation calls for continued rigorous research to fully explore acupuncture’s therapeutic potential and its integration into evidence-based medicine,ultimately contributing to improved patient care and broader acceptance within the medical community.展开更多
Aiming at the conclusion that ＂there is no difference in efficacy between acupuncture and sham-acupuncture＂ in clinical research field of migraine in foreign countries in recent years, through the discussions on the...Aiming at the conclusion that ＂there is no difference in efficacy between acupuncture and sham-acupuncture＂ in clinical research field of migraine in foreign countries in recent years, through the discussions on the definition of sham acupuncture （placebo acupuncture）, the principles required to be obey in satisfactory placebo acupuncture, the definition, location, function as well as clinical results of shallow puncture, the authors probed into whether shallow puncture could be the control method of sham acupuncture （placebo acupuncture） in clinical research of acupuncture. It was demonstrated in the results that ＂acupuncture with minimal stimulation on skin superficial layer of meridian points or non-meridian points＂, the so-called control method of ＂sham acupuncture （placebo acupuncture）＂ excited holistic regulation of human body quite probably through ＂shallow puncture on cutaneous region of meridians＂ to achieve therapeutic effects. Hence, this method is not the appropriate control method of placebo acupuncture and cannot be the control method of sham acupuncture （placebo acupuncture） in clinical research of acupuncture. Therefore, it is naturally to repudiate the conclusion that ＂there is no difference in efficacy between acupuncture and sham acupuncture＂ in the research where this method is taken as the control of placebo acupuncture.展开更多
Objective： Different kinds of sham acupuncture are widely applied in randomized controlled trials （RCTs） to explore whether acupuncture has intrinsic therapeutic effects beyond the placebo effects for certain indic...Objective： Different kinds of sham acupuncture are widely applied in randomized controlled trials （RCTs） to explore whether acupuncture has intrinsic therapeutic effects beyond the placebo effects for certain indication. To make conclusions of trials more comparable and convincing, it is of great necessity to unify the sham acupuncture procedure. Methods： RCTs of acupuncture with high quality in the recent 14 years were reviewed, and the appropriateness of the sham acupuncture procedures was assessed. Results： The sham acupuncture procedures were mainly classified into five kinds according to their administered sites, penetrating, and intervention apparatus. Conclusion： Among the sham acupuncture procedures, needling near the selected acupoints, needling at a distant non-acupoints, and non-penetrating sham acupuncture are most commonly used. Sham acupuncture performed at distant site belongs to non-meridian and non-acupoint may be an ideal control for the study of the intrinsic therapeutic effects of acupuncture. Besides, the selection of controls must focus on the design and aim of RCTs, such as non-inferiority, equivalence and superiority trials.展开更多
文摘This study examined the application of the Rumsfeld Matrix to acupuncture clinical trials,particularly those published in leading medical journals such as The Journal of the American Medical Association(JAMA),British Medical Journal(BMJ),The Lancet,and The New Eng-land Journal of Medicine(NEJM).The integration of randomized clinical trials(RCTs)has in-troduced a level of academic rigor to acupuncture research,challenging the classical deter-ministic model and revealing a complex landscape of known knowns,known unknowns,un-known knowns,and unknown unknowns.While RCTs have validated acupuncture’s efficacy in certain conditions,they have also highlighted considerable challenges,including the limi-tations of control group designs and the potential influence of placebo effects.The recurring issue of no significant differences between real and sham acupuncture in many studies un-derscores the need for refined control strategies and a more nuanced understanding of acupuncture’s mechanisms.This investigation calls for continued rigorous research to fully explore acupuncture’s therapeutic potential and its integration into evidence-based medicine,ultimately contributing to improved patient care and broader acceptance within the medical community.
基金Academy-rank research project of China Academy of Chinese Medical Sciences:ZZ 2006084
文摘Aiming at the conclusion that ＂there is no difference in efficacy between acupuncture and sham-acupuncture＂ in clinical research field of migraine in foreign countries in recent years, through the discussions on the definition of sham acupuncture （placebo acupuncture）, the principles required to be obey in satisfactory placebo acupuncture, the definition, location, function as well as clinical results of shallow puncture, the authors probed into whether shallow puncture could be the control method of sham acupuncture （placebo acupuncture） in clinical research of acupuncture. It was demonstrated in the results that ＂acupuncture with minimal stimulation on skin superficial layer of meridian points or non-meridian points＂, the so-called control method of ＂sham acupuncture （placebo acupuncture）＂ excited holistic regulation of human body quite probably through ＂shallow puncture on cutaneous region of meridians＂ to achieve therapeutic effects. Hence, this method is not the appropriate control method of placebo acupuncture and cannot be the control method of sham acupuncture （placebo acupuncture） in clinical research of acupuncture. Therefore, it is naturally to repudiate the conclusion that ＂there is no difference in efficacy between acupuncture and sham acupuncture＂ in the research where this method is taken as the control of placebo acupuncture.
基金National Natural Science Foundation of China (No. 30873299, 90409014, 81001548, 30701123)Shanghai Leading Academic Discipline Project (S30304)
文摘Objective： Different kinds of sham acupuncture are widely applied in randomized controlled trials （RCTs） to explore whether acupuncture has intrinsic therapeutic effects beyond the placebo effects for certain indication. To make conclusions of trials more comparable and convincing, it is of great necessity to unify the sham acupuncture procedure. Methods： RCTs of acupuncture with high quality in the recent 14 years were reviewed, and the appropriateness of the sham acupuncture procedures was assessed. Results： The sham acupuncture procedures were mainly classified into five kinds according to their administered sites, penetrating, and intervention apparatus. Conclusion： Among the sham acupuncture procedures, needling near the selected acupoints, needling at a distant non-acupoints, and non-penetrating sham acupuncture are most commonly used. Sham acupuncture performed at distant site belongs to non-meridian and non-acupoint may be an ideal control for the study of the intrinsic therapeutic effects of acupuncture. Besides, the selection of controls must focus on the design and aim of RCTs, such as non-inferiority, equivalence and superiority trials.
