针灸临床研究针刺安慰对照方法的设计与实践

Design and Practice of Acupuncture Placebo-controlled Method in Clinical Studies of Acupuncture

针对近年来国外一些针灸临床研究获得的针刺与针刺安慰对照的疗效差异无统计学意义的研究结论,分析目前国外针灸临床研究常用针刺安慰对照方法的不足,力求建立更加科学完善的、适合中国国情的、并能得到国际认可的针灸对照试验对照组针刺安慰对照方法。本文探索一种新的针刺安慰对照方法,在获得患者充分信任的前提下,使安慰对照组潜在的治疗作用最小化,发挥更理想的安慰剂作用。通过实践,针对针刺与药物作对照的随机对照研究,借助临床新药研究双模拟的思路,建立"双模拟-非病症相关穴-随机抽样"对照法,形成新型的针灸与药物作对照的针灸临床研究模式。

Based on the conclusion of recent clinical research conducted by foreign countries,there is no statistical difference in outcomes between real and placebo acupuncture.This paper analyzes the weaknesses of methods currently being used by foreign countries to compare the effects of real and placebo acupuncture,striving for a new way to test for the placebo effect;a way that is more scientific,more suitable for the current conditions of China,while at the same time capable of being recognized internationally.This paper describes a new acupuncture placebo-controlled method.Under the condition of complete patient trust,we may ensure an ideal placebo effect to the greatest extent by minimizing the potential curative effects in the placebo group.From the actual clinical practice,by randomized controlled trial comparing acupuncture and medicine,using the concept as the double-dummy clinical trail,this paper explores the 'double-dummy – non-specific sites – random sampling' method in the clinical setting as a way to form a new acupuncture clinical research model of comparison between acupuncture and medicine.