目标疾病导向下针刺临床研究安慰对照设计方法的建立

Previously developed acupuncture placebos have been reported to possess various kinds of imperfections. Guided by evidence-based medicine theories, we have made an initial attempt to establish a set of control methods for use in acupuncture studies, which is named the "target disease-guided" placebo-controlled design, in the hope that this technique may eliminate the placebo effects that confound the results of acupuncture trials.In this design, the interventions used in the treatment and control group are identical, so that the acupuncture placebo shall be indistinguable from the real treatment in appearance and the sensation it produced. In a randomized double-blind controlled trial, 90 patients simutanneously suffering from migraine and constipation were randomly divided into three groups. While patients in Group 1 and 2 received the same acupuncture therapy (for migraine), they were told to receive migraine treatment in Group 1 and constipation treamment in Group 2. Group 3 reveived superfacial stimulation in non-acupoints. Then, we evaluated the outcomes of each group and elicited the effect size of the placebo effects for migraine or constipation through between-group comparisions. Moreover, conclusions on the feasibility of the control design can be made by comparing the target disease-guided placebo control with the traditionally used sham acupuncture (superfacial stimulation in non-acupoints). We believe the proposed design may provide an effective tool for control of palcebo effects in acupuncture and evoke thoughts for clinical researchers.

既往安慰针刺方法存在各种缺陷，无法充分体现针刺的真实疗效，且难以消除安慰剂效应。本课题遵循循证医学理念，根据针刺疗法的独特性，探索建立一种针刺临床研究安慰对照设计新方法--目标疾病导向安慰法。该方法的特点在于治疗组与对照组采用完全相同的干预措施，从而有效解决目前各种安慰针法中无法回避的难题--两组干预措施在外观、感觉上不能做到完全一致。本课题采用随机对照设计，选择偏头痛与便秘为目标疾病，将90例受试者随机分三组，采用针刺干预配合不同疾病导向心理暗示，组1和组2接受相同针刺干预，组1被告知针刺仅对偏头痛有效，组2被告知针刺仅对便秘有效，组3接受假穴浅刺法，分别评价各组结局。明确在相同干预措施下不同疾病的安慰效应量大小，验证目标疾病导向安慰法是否优于假穴浅刺法，确立并完善目标疾病导向安慰法。该方法将在一定程度上弥补当前针刺临床研究中安慰对照设计的不足，为针刺临床研究的科学合理设计提供新的思路。

课题遵循循证医学理念，根据针刺疗法的独特性，探索建立了一种针刺临床研究安慰对照设计新方法——目标疾病导向安慰法。课题采用随机对照设计，选择偏头痛与失眠为目标疾病，将受试者随机分三组，采用针刺干预配合不同疾病导向心理暗示，组1和组2接受相同针刺干预，组1被告知针刺仅对偏头痛有效，组2被告知针刺仅对失眠有效，组 3接受假穴浅刺法，分别评价各组对偏头痛及失眠各项指标的结局。结果显示，目标疾病导向安慰方法下，剥离安慰剂效应后对偏头痛的针刺疗效与假穴浅刺的疗效进行比较，在头痛指数，即刻VAS评分，现有痛强度PPI和疼痛分级指数PRI四个方面差异均有统计学意义；对偏头痛指标的组间比较提示，ARM1组的评分值下降趋势最优，ARM2组其次，ARM3组评分值下降不明显，考虑与ARM2组相比较，ARM1组对偏头痛存在安慰剂效应的缘故，且两组对偏头痛的改善趋势优于ARM3假穴浅刺组；对失眠指标的组间比较提示，ARM2组疗效优于ARM3假穴浅刺组与ARM1组，推测在目标疾病导向方法下，ARM1组为针刺作用，在此基础上，ARM2组对失眠存在安慰剂效应，而ARM3组仅为假针刺作用，因此次要疾病的疗效ARM2组最优。通过本方法的实施，证实了目标疾病导向下的安慰设计方法使不同组别人群分别产生了对偏头痛的安慰剂效应和对失眠的安慰剂效应。检验了在剥除安慰剂效应后针刺对目标疾病的真实效应，对偏头痛各项指标的分析证实了针刺对偏头痛的疗效，验证了目标疾病导向安慰法应用于针刺临床评价的可行性。