刘京;王俊英;刘俊岭;朱兵;
LIU Jing,WANG Jun-ying1,LIU Jun-ling1,ZHU Bing1(Massachusetts General Hospital,Harvard Medical School,Boston,Chariestown,MA 02129,USA;1Institute of Acu-moxibustion,China Academy of Chinese Medical Sciences,Beijing 100700,China)

• 1:美国麻省总医院
• 2:中国中医科学院针灸研究所
• 3:中国中医科学院针灸研究所
• 4:中国中医科学院针灸研究所 麻萨诸塞02129

摘要(Abstract)：

安慰对照已普遍用于临床研究,目的在于使心理因素降低到最小。然而,还没有见到最理想的安慰/假针刺设计用于针刺研究。因此,许多针灸临床研究并不符合设计常规临床试验的标准。弄清针灸安慰效应和药物学研究的差异是回答此种具有挑战问题的关键。在临床设计中为了避免失败,应当恰当地考虑安慰剂及假穴位的概念、穴位及经脉作用的特异性等。在以往的针灸研究中,对假穴位对照的设计常常拘泥于安慰剂定义。与化学药物作用于特异性受体不同,针刺可对机体多系统、多脏器、多种细胞、多种神经递质及调质、激素、多种受体产生影响。也正因为如此,针刺治疗如疼痛、紧张情绪等症状的临床效果常被斥之为是安慰效应。功能性核磁共振和其它许多研究提供的证据强烈提示:针刺对脑内多个心理和情感控制中枢,如边缘系统、前额叶皮层等有明显影响,从而导致一系列的功能调节,也可产生一定的安慰效果,但这种安慰效果对病人来说也是有益的。所以,针刺可能是治疗身心疾病的一种独特的疗法,安慰对照在针灸临床研究中需要重新评价。
Placebo controls have often been used in standard clinical studies in order to minimize the effects of psychological interference.However,no ideal placebo(including false needle technique)has been designed for the purpose of acupuncture research.As a result,many of the clinical studies of acupuncture do not follow proper criteria for designing a conventional clinical trial.Understanding the differences of the placebo effect in acupuncture and pharmaceutical drug research is the key to answering this challenge.To do this,the concept of placebo,sham point,acupuncture point specificity and meridian all need to be properly considered in order to avoid a failure in clinical design.The sham points control in the previous acupuncture studies often obeyed the definition of the placebo.Being different from drugs which act upon pre-designed specific receptors,acupuncture may have various effects on multiple systems,organs and a lot of cells and receptors,multiple transmitters,hormones,etc..For this reason,the results of acupuncture treatment,such as pain relief and relaxation,have been criticized as a "placebo" effect.However,evidence from fMRI and other studies strongly suggest that acupuncture affects multiple psychological and emotional control centers of the brain,such as the limbic system and the prefrontal cortex.This may result in a series of functional modulations,which involves pain and stress management.The results suggest that the placebo effect could be induced by non-specific physical stimulation of acupuncture and may favor the patient's health recovery to a certain degree.From this point of view,acupuncture may be a unique remedy for "mind-body" disorders.The current placebo control design in clinical trials of acupuncture needs to be reevaluated.

关键词(KeyWords)： 针灸临床研究;安慰/假针刺对照;循证医学;随机双盲试验
Acupuncture clinical trials;Placebo/sham acupuncture;Evidence-based medicine;Randomized controlled trials

Abstract:

Keywords:

基金项目(Foundation):

作者(Author): 刘京;王俊英;刘俊岭;朱兵;
LIU Jing,WANG Jun-ying1,LIU Jun-ling1,ZHU Bing1(Massachusetts General Hospital,Harvard Medical School,Boston,Chariestown,MA 02129,USA;1Institute of Acu-moxibustion,China Academy of Chinese Medical Sciences,Beijing 100700,China)

Email:

DOI:

参考文献(References)：

• 1吴滨,刘屹,何竟,等.针灸临床防治性研究中对照组设立的探讨.中国循证医学,2002,2(2):2-3.
• 2张宏伟,唐金陵.针灸临床试验中安慰针的设计与选用.中国中西医结合杂志,2003,23(4):247-250.
• 3Macklin E A,Wayne P M,Kalish L A,et al.Stop hypertension with the acupuncture research program(SHARP):results of a randomized,controlled clinical trial.Hypertension,2006,48(5):838-845.
• 4Haake M,Muller H,Schade-Brittinger C,et al.The German multicenter,randomized,partially blinded,prospective trial of acupuncture for chronic low-back pain:a preliminary report on the rational and design of the trial.J Altern Compl Med,2003,9(5):763-770.
• 5Melchart D,Streng A,Hoppe A,et al.Acupuncturein patients with tension-type headache:randomized controlled trial.BMJ,2005,331(7513):376-382.
• 6于强.针灸疗效评价中盲法和安慰剂的选择.中西医结合心脑血管病杂志,2003,1(4):196-198.
• 7Sherman KJ,Hogeboom C J,Cherkin D C,et al.Description and validation of a noninvasive placebo acupuncture procedure.J Altern Compl Med,2002,8(1):5-6.
• 8Streitberger K,Kleinhenz J.Introducing a placebo needle into acupuncture research.Lancet,1998,352(9125):364-365.
• 9黄梅芳,俞昌德.安慰对照针灸方法的可信性测试.中国针灸,2004,24(7):507-509.
• 10Lewith G T,Field J,Machin D.Acupuncture compared with placebo in post-herpetic pain.Pain,1983,17(4):361-368.
• 11Heeg MJ,Deutsch K F,Deutsch E.The placebo effect.Euro-pean J Nucl Med,1997,24(11):1433-1440.
• 12Kong J,Ma L,Gollub R L,et al.A pilot study of functional magnetic resonanceimaging of the brain during manual and elec-troacupuncture stimulation of acupuncture point(LI-4Hegu)in normal subjects reveals differential brain activation between methods.J Altern Compl Med,2002,8(4):411-419.
• 13Zald D H.The human amygdale andthe emotional evaluation of sensory stimuli.Brain Res Rev,2003,41(1):88-123.
• 14Kathleen H,Liu J.Theintegrated response of the human cere-bro-cerebellar and limbic systems to acupuncture stimulation at ST36as evidenced by f MRI.Neuroimage,2005,27(3):479-496.
• 15Vogt B A.Pain and Emotion interaction in subregions of the cingulated gyrus,focus on pain.Nat Rev Neurosci,2005,6(7):533-544.
• 16Dhond R P,Kettner N,Napadow V.Do the neural correlates of acupuncture and placebo effects differ.Pain,2007,128(1/2):8-12.
• 17Fang J L,Krings T,Weidemann J,et al.Functional MRI in healthy subjects during acupuncture:different effects of needle rotation in real and false acupoints.Neuroradiology,2004,46(5):359-362.
• 18Yan B,Li K,Xu J Y,et al.Acupoint-specific f MRI patternsin human brain.Neurosci Lett,2005,383(3):236-240.
• 19Harrington A.The placebo effect.Boston:Harvard University Press,1997:1-36.
• 20Campbell A.Point specificity of acupuncture in the light of re-cent clinical and imaging studies.Acupunct Med,2006,24(3):118-122.
• 21郭佳.对比分析针灸临床研究与国际接轨差距.中国针灸,2004,24(1):3-6.
• 22Miller F G,Kaptchuk T J.Acupuncture trials and informed consent.J Med Ethics,2007,33(1):43-44.
• 23Endres H G,Zenz M,Schaub C,et al.German acupuncture trials(gerac)address problems of methodology associated with acupuncture studies.Schmerz,2005,19(3):201-204.
• 24Berman B M,Lao L,Langenberg P,et al.Effectiveness of acu-puncture as adjunctive therapy in osteoarthritis of the knee:a randomized,controlled trial.Ann Int Med,2004,141(12):901-910.