摘要
背景
针灸疗法以其简、便、效、廉的特点广泛地应用于疾病的预防和治疗,大量的临床实践和古今医学文献都记载和报道了针灸的临床疗效,尤其是无药物毒副作用的优点符合当今自然疗法的大趋势。而当前国外大量的对针灸疗效的系统评价结论是“不确定”。这可能与这些研究的方法学方面存在的不足有关,这些不足包括治疗方案不合适、样本量过小、随机方法不恰当、对照组设立不合理、缺少明确的纳入/排除标准及客观的疗效评价方法、盲法设计不当、随访时间太短以及统计方法不恰当等多方面的原因。近年来,在国际影响因子较高的权威杂志发表的多项关于针刺治疗慢性腰背痛、膝骨关节炎、纤维肌痛等的大样本的随机对照试验均得出治疗针刺效应与安慰针刺效应无显著差异的结论。即针刺效应等同于安慰剂效应。上述结论使得针灸的疗效在国际上遭到质疑甚至否定,因此,如何客观合理的评价针灸疗法的临床疗效,使得针灸疗法能够被国际社会广泛接受与认同,是当前国内针灸界亟需解决的问题。
随机对照试验是临床流行病学中公认的评价临床治疗性研究的金标准,随着循证医学和临床流行病学的不断发展,使临床研究水平不断提高。而随机化、对照组设立、盲法以及基线可比性是随机对照试验所应遵循的四大原则。纵观当前国际发表的针灸临床随机对照试验,绝大部分是以安慰针刺作为对照组,而作为对照组的安慰针刺设计的变化主要集中在是针刺部位和针刺深度的变化方面,针刺部位可分为特异治疗穴位点、非特异治疗穴位点和非穴位点三种。而针刺深度主要有皮表、浅刺(即皮下1-4mm)和深刺(即皮下10-20mm)之分。因此二者结合,可有穴位点/非穴位点/非特异治疗穴位点皮表针、非穴位点/非特异治疗穴位点深刺针、穴位点/非穴位点/非特异治疗穴位点浅刺针三大类。因此,当前存在的安慰针刺方法种类繁多,在已发表的针灸随机对照试验中均有应用,但是未具备统一的应用标准,针对不同疾病针灸治疗的随机对照试验有可能应用设置相同的安慰针刺对照,而针对同一种疾病针灸治疗的随机对照试验亦有可能使用设置不同的安慰针刺。因而当前国内外针刺临床研究的安慰针刺设置并未考虑到疾病状态的不同,而机能状态、刺激部位、刺激参数是影响针刺效应的因素,因此我们认为：当前针刺效应不能够得到合理证实的主要原因之一有可能是对照组安慰针刺设置的不合理所导致。
本研究来源于国家“十二五”科技支撑计划项目“针灸疗效国际多中心临床评价研究”(项目编号：2012BAI24B00),以影响针刺效应的因素(机能状态、刺激部位、刺激参数)为切入点,认为安慰针刺作为治疗针刺的一种特殊形式,其效应亦取决于上述影响因素。而当前国内外针灸临床研究中,安慰针刺对照设置的方法种类繁多,取得的结局亦参差不齐,其中相当一部分研究取得了阴性结局。但是安慰针刺作为治疗针刺的一种特殊形式,其设置方法也是集中在刺激部位和刺激强度的变化两个方面,因此我们在Pubmed文献数据库中检索了近十年来涉及安慰针刺对照的随机对照试验文献,按照疾病种类、刺激部位、刺激强度分类,以期了解针灸临床研究中安慰针刺对照设置的现状与存在的问题,在此基础上我们提出假说：机体状态、针刺部位、刺激强度共同决定了安慰针刺效应的大小,机体状态不同,针刺部位与刺激强度对安慰针刺效应影响的强弱也不同。疼痛类疾病中,刺激对安慰针刺效应的影响要大于针刺部位对其的影响；而在非疼痛类疾病中,针刺部位对安慰针刺效应的影响要大于刺激对其的影响。
为了验证上述假说,我们收集近十年国内发表的针刺临床研究文献,并分为疼痛类疾病和非疼痛类疾病,采用特征选择算法对文本数据进行处理,探索不同疾病状态下影响针刺效应的因素,据此推断影响安慰针刺效应的关键因素,并采用动物实验“不同针刺部位、不同强度的刺激对大鼠C-纤维反射抑制效应的观察”进一步深入探索影响疼痛类疾病安慰针刺效应的因素。最后,提出对于疼痛类疾病安慰针刺合理设置的建议。
目的
探索疼痛类疾病状态下影响安慰针刺效应的关键因素。
方法
1.针灸临床研究中安慰针刺对照设置的现状与问题研究
检索近十年来Pubmed文献数据库中所有以安慰针刺作为对照的随机对照试验文献,应用文献计量法对安慰针刺设置的方法进行梳理和总结,得出当前针灸临床研究中安慰针刺对照的现状以及存在的问题,并提出假说：机体状态、针刺部位、刺激强度共同决定了安慰针刺效应的大小,机体状态不同,针刺部位与刺激强度对安慰针刺效应影响的强弱也不同。疼痛类疾病中,刺激对安慰针刺效应的影响要大于针刺部位对其的影响；而在非疼痛类疾病中,针刺部位对安慰针刺效应的影响要大于刺激对其的影响。
2.不同疾病状态下影响针刺效应的因素研究
利用现有的针刺临床研究的数据,提取与针刺效应相关的信息,采用数据挖掘中的特征选择分析方法,探索影响对照组与治疗组疗效差异的关键因素,进而确定影响针刺效应的关键因素。即采用经典的CfsSubsetEval特征选择算法,通过BestFist迭代方法求解算法的参数,估计影响针刺效应的指标子集中每一个因素的预测能力。
3.影响疼痛类疾病安慰针刺效应因素的实验研究
通过实验研究来探索影响疼痛类疾病安慰针刺效应的关键因素,在本实验研究中,我们分别采用损伤极小的SD大鼠C-类纤维反射为伤害性反应指标,在测定每一实验对象反射阈值的基础上,以其自身阈值为客观依据,充分考虑穴位的神经节段关系,分别研究不同倍数的阈强度的电针和不同刺激强度的毫针刺激不同部位而引起镇痛效应的差异。刺激部位选取与诱发C-类纤维反射的伤害性刺激同神经节段的同侧足三里及其旁开的部位,以及异位同节段的对侧足三里及其旁开部位,远端异神经节段的手三里及其旁开部位,充分考虑到了刺激部位与痛源部位的位置关系,电针的刺激量也选取了易于控制刺激强度的电刺激,电流强度分别为0.6Tc,Tc,1.5Tc,其中,Tc表示引起动物C-类纤维反射的最小刺激强度。在进行手针刺激时,刺激量的变化主要是集中在针刺深度和是否实施手法两个方面。
结果
1.以安慰针刺作为对照组的临床文献研究
1.1运用安慰针刺对照的文献涉及的病种及主要安慰针刺设置方法概况：近十年来Pubmed数据库中,约50%左右的疾病以疼痛为主要症状,如慢性腰痛、慢性颈肩痛、头痛等；或者针刺治疗针对该疾病的疼痛症状,如膝骨关节炎,颞下颌关节紊乱,风湿性关节炎等。而另外约50%针刺治疗的疾病多与疼痛无关,而与脏腑关窍的功能有关：如耳鸣、过敏性鼻炎、高血压、原发性失眠、围绝经期综合征等。疼痛类疾病安慰针刺设置方法中,出现频次最高的是治疗穴位的非刺入假针(36.99%),其次为非经非穴点的浅刺(28.77%)。非疼痛类疾病的安慰针刺设置中非经非穴点的浅刺(19.70%)出现频次最高,其次为非经非穴点的不刺入(18.18%)和非经非穴点的深刺(16.67%)以及非治疗穴位的深刺(16.67%)。
1.2疼痛类疾病文献分析的结果显示：按照安慰针刺部位是否为治疗穴位分类,治疗穴位的安慰针刺取得阳性结局的百分比为62.5%,非治疗穴位组(总)的安慰针刺取得阳性结局的百分比为51.22%,非穴位组的安慰针刺取得阳性结局的百分比为55.88%。痛源远端的安慰针刺取得阳性结局的百分比为61.11%,痛源近端的安慰针刺取得阳性结局的百分比为54.55%。而根据针刺深度不同分类,得出非刺入的安慰针刺取得阳性结局的百分比为67.86%,刺入皮肤的安慰针刺设置取得阳性结局的百分比为48.89%,浅刺的安慰针刺设置取得阳性结局的百分比为51.85%,深刺的安慰针刺设置取得阳性结局的百分比44.44%。
1.3非疼痛类疾病安慰针剌对照的文献分析结果显示：按照安慰针刺部位是否为治疗穴位分类,治疗穴位的安慰针刺取得阳性结局的百分比为57.14%,非治疗穴位组(总)的安慰针刺取得阳性结局的百分比为67.31%,非穴位组的安慰针刺取得阳性结局的百分比为61.11%。而根据针刺深度不同分类,得出非刺入的安慰针刺取得阳性结局的百分比为52.00%,刺入皮肤的安慰针刺设置取得阳性结局的百分比为73.17%,浅刺的安慰针刺设置取得阳性结局的百分比为78.95%,深刺的安慰针刺设置取得阳性结局的百分比68.18%。
2.不同疾病状态下影响针刺效应的因素研究结果
纳入的针刺临床研究数据包括电针治疗研究和毫针治疗研究两个部分,每个部分都根据疾病种类分为疼痛类疾病研究和非疼痛类研究,根据特征选择算法CfsSubsetEval得出各类研究中治疗组与对照组最具有区分度的指标,即对针刺效应影响较大的因素。
2.1电针研究中的疼痛类疾病文献数据分析结果显示：治疗组与对照组最具区分度的指标依次为：手法、针刺深度、手法频率、针刺部位、电针波形。
2.2电针研究中的非疼痛类疾病文献数据分析结果显示：治疗组与对照组最具区分度的指标依次为：手法、针刺部位、电针波形、手法频率、针刺深度、电针频率。
2.3毫针研究中的疼痛类文献数据进行分析结果显示：治疗组与对照组最具区分度的指标依次为：手法、手法频率、针刺深度、手法幅度、针刺部位。
2.4毫针研究中的非疼痛类文献数据分析结果显示：治疗组与对照组最具区分度的指标依次为：针刺部位、手法频率、手法幅度、针刺深度、手法。
3.不同针刺部位、不同强度的刺激对大鼠C-类纤维反射抑制效应的观察结果
3.1电针刺激不同部位,不同刺激强度对大鼠C-类纤维反射抑制的效应实验结果显示：弱刺激(0.6Tc)同节段的同侧足三里,对C-类纤维反射抑制效应较强(P<0.05,P<0.01),而弱刺激(0.6Tc)远端异节段的手三里或者异位同节段的对侧足三里,对C-类纤维反射抑制效应不明显(P>0.05)；当电刺激强度较强时(Tc/1.5Tc),不论是同侧同节段足三里、异位同节段的对侧足三里,以及远端的异神经节段的手三里对C-类纤维反射抑制效应均较强(P<0.01)；对于同一刺激部位,随着刺激强度的增大,对C-类纤维反射抑制效应亦随之增强(P<0.01)；同样的刺激强度下,对于同一穴位及其旁开的非经非穴点,对C-类纤维反射的抑制效应没有显著差异(P>0.05)。
3.2手针刺激不同部位,不同刺激强度对大鼠C-类纤维反射抑制的效应实验结果显示：弱刺激(浅刺无手法)与C-类纤维反射同节段的同侧足三里,对C-类纤维反射抑制效应较强(P<0.05,P<0.01),而弱刺激(浅刺无手法)远端异节段的手三里或者异位同节段的对侧足三里,对C-类纤维反射抑制效应不明显(P>0.05)；当刺激强度较强时(深刺/深刺+捻转),不论是同侧同节段足三里、异位同节段的对侧足三里,以及远端的异神经节段的手三里对C-类纤维反射抑制效应均较强(P<0.01)；对于同一刺激部位,随着刺激强度的增大,对C-类纤维反射抑制效应亦随之增强(P<0.05,P<0.01)；同样的刺激强度下,对于同一穴位及其旁开的非经非穴点,对C-类纤维反射的抑制效应没有显著差异(P>0.05)。
结论
1.由于针灸临床研究的特殊性和复杂性,使得安慰针刺产生的效应很难等同于安慰剂效应,从近十年来Pubmed文献数据库中所有以安慰针刺作为对照的随机对照试验文献检索结果中的安慰针刺设置方法的角度来看,安慰针刺可以看作治疗针刺的特殊形式,当治疗针刺的效应达到最小时便可以作为理想的安慰针刺。
2.作为治疗针刺的一种特殊形式,影响治疗针刺效应的因素亦同样适用于安慰针刺的效应,不同疾病状态下影响针刺效应的因素研究结果表明,在不同的疾病状态下,针刺部位和刺激对针刺效应的影响程度亦不相同。因此在进行安慰针刺设置时,除去需要考虑针刺部位与针刺深度外,还应考虑到不同的疾病状态对安慰针刺效应的影响。
3.影响疼痛类疾病安慰针刺效应因素的实验研究结果表明,疼痛类疾病的安慰针刺效应主要取决于刺激强度,以及针刺部位与痛源的相对位置,而非取决于针刺部位是否为治疗穴位。当刺激部位与痛源处于同一神经节段时,不论弱刺激或强刺激均可产生镇痛效应；当刺激部位与痛源处于异神经节段的远端时,强刺激才能产生镇痛效应。因此,对于疼痛类疾病临床研究的安慰针刺的设置应当在与痛源部位处于异神经节段的远端部位进行弱刺激。
创新点
本研究从安慰针刺对照组合理设置的角度,阐释了如何应用国际通用的临床流行病学和循证医学的方法对针灸疗效进行客观、合理的评价,从而使得针灸疗法能够被国内外广泛认同并接受,具有非常重要的现实意义。疼痛类疾病安慰针刺效应的关键影响因素研究,是一项具有开创性意义的研究,是针灸临床疗效评价的重要环节。本研究的主要创新点包括：
1.将安慰针刺作为治疗针刺的一种特殊的形式研究,当治疗针刺的效应达到最小时便可以作为理想的安慰针刺。
2.从影响针刺效应的因素角度研究影响安慰针刺效应的关键因素,认为影响治疗针刺效应的因素亦同样适用于安慰针刺的效应。
3.提出疼痛类疾病的安慰针刺效应主要取决于刺激强度,以及针刺部位与痛源的相对位置。
Background
Acupuncture therapy, which is quite effective and can be afford by most of people, is widely used in disease prevention and treatment and conforms to the trend in today's natural therapies especially without the advantages of drug side effect. The clinical curative effect of acupuncture has been demonstrated by a large number of clinical practice and medical literature. A large number of foreign systems reviews of acupuncture efficacy evaluation findings are "uncertain" currently. This may due to some methodological deficiencies including inappropriate treatment regimens, small sample size, inappropriate random approach, improper control group design, the lack of explicit inclusion/exclusion criteria, the lack of objective efficacy evaluation method, poor blinding design, inadequate follow-up period and wrong statistical methods and so on. A number of RCTs published of acupuncture treatment of knee osteoarthritis, chronic low back pain and fibromyalgia show that acupuncture effect has no significant difference with placebo needles. Acupuncture effect is equivalent to the placebo effect, namely the acupuncture invalid. This conclusion has caused the efficacy of acupuncture be questioned and even denied, therefore, how to evaluate acupuncture efficacy objectively and reasonably so that acupuncture therapy can be widely accepted by the international community, is a quite urgent problem to solve for domestic acupuncture profession.
Randomized controlled trial has now been recognized as the gold standard for clinical therapeutic trials method. As the development of clinical epidemiology, clinical treatment level has improved a lot. As is known to all, randomization, control group set up, blinding and baseline comparability are four principles that randomized controlled trials should follow. Most of the acupuncture clinical randomized controlled trials take plcebo needle as a control group, whose design change is mainly concentrated on the needle sites and depth, needle sites can be divided into acupoints of specific treatment, nonspecific acupoints and non-acupoints. Needle depth can be divided into non-penetrated needle, superficial needle(1-4mm) and deep needle(i.e., subcutaneous10-20mm). Therefore, the combination of both, may have three categories, including non-penetrated needling at acupoints/non-acupoints/non-specific acupupoints, superficial needling acupoints/non-acupoints/non-specific acupupoints and deep needling at acupoints/non-acupoints/non-specific acupupoints. Currently, placebo needle design method exists a wide range of applications, but there is not an uniform standards of application in acupuncture RCTs.Treatment for different diseases with the same set of placebo acupuncture While treatment for the same disease is also possible to use a different set of placebo needle.Thus, acupuncture clinical research at home and abroad did not take the different disease states into account. Functional status, the site of stimulation, stimulation parameters are the factors that affect the acupuncture effect, so we inferred that:acupuncture effect can not be reasonably confirmed may due to the that inappropriate placebo needle design.
This study belongs to the National Twelfth Five-Year "scientific and technological support projects" the clinical evaluation of acupuncture efficacy in international multi-center "(Item Number:2012BAI24B00). We took factors (functional status, the site of stimulation, stimulation parameters)that affect the acupuncture effect as the breakthrough point,believed that placebo acupuncture as a special form of acupuncture treatment, its effect also depends on these influencing factors. so we retrieved all the RCTS with placebo needle as control group of the Pubmed database over the past decade, classified according to the disease types, stimulation sites and stimulus intensity, in order to summarize the current situation and existing problems of the placebo needle control in acupuncture clinical studies. On this basis we propose a hypothesis:the size of the placebo needle effect is determined by body state, acupuncture site and stimulus intensity. Acupuncture site and stimulus intensity will cause different effects if people are in different body states. In pain disease, stimulus intensity has more influence than acupuncture site does on placebo needle effect, while in the disease not pain related, acupuncture site has more influence.
In order to verify the hypothesis, we collected acupuncture clinical research literature published in China in recent years, which is divided into pain disease and non-pain-like disease, applied feature selection algorithm for processing text data to explore the impact of acupuncture effect in various disease states in order to infer key factors that affect the placebo needle effect. And then we launched the animal experiments " Observation of rat C-fiber reflex inhibition effect of the different puncture site and stimulus intensity "to further explore the key factors that affect the placebo needle effect. Finally, recommendations of placebo needle design for pain disease was made.
Objective
To explore the key factors that affects the placebo effect of pain disease
Method
1. Research on current situation and problems of placebo needles design
This study retrieved all the RCTS with placebo needle as control group of the Pubmed database over the past decade and then summarized the current situation and existing problems of the placebo needle control in acupuncture clinical studies. We proposed the hypothesis that:the size of the placebo needle effect is determined by body state, acupuncture site and stimulus intensity. Acupuncture site and stimulus intensity will cause different effects if people are in different body states. In pain disease, stimulus intensity has more influence than acupuncture site does on placebo needle effect, while in the disease not pain related, acupuncture site has more influence.
2. Research on the factors influencing acupuncture effect under different disease states
We extract information related to the acupuncture effect from the existing acupuncture clinical research data, and try to find the difference between the control group and the treatment group, which will be the key factors determining the effect of acupuncture. The parameters of the algorithm can be achieved by BestFist iteraitive method and the classic CfsSubsetEval features selection algorithm, one of the feature selection methods in data mining analysis. The parameters are regarded as the indicators of the predictive power of each of these factors subset.
3. Experimental research on the factors influencing placebo needle effects of pain disease
We explored the key factors that affect the placebo acupuncture effect of pain disease with experimental studies. in this experimental study, we used C-fiber reflex which has minimal damage to the SD rats as nociceptive response indicators. We determined the C-fiber reflex threshold of each experimental rats and studied differences in analgesic effect caused by different multiples of the threshold intensity EA and stimulus intensity needles to stimulate different parts based on their objective basis and nerve segment relations. The site of stimulation were the acupoint of Zusanli and the nonacupoint next to it, which were on the same side of the same nerve segmental region with the noxious stimulation that can induce the C-fiber reflex. The ectopic same segment contralateral Zusanli and Shousanli in remote different nerve segment and the nonacupoints next to them respectively were also selected to make sure give full consideration on the positional relationship of the site of stimulation and pain source parts. Electro-acupuncture stimulus intensity were applied0.6Tc, Tc,1.5Tc repectively as current intensity, where, Tc is the minimum stimulus intensity which can cause the C-fibers reflex of the animal. During hand stimulation, changes in the amount of stimulation is mainly concentrated in acupuncture depth and technique implementation.
Results
1. Document research on literature with placebo needle as control group
1.1The disease and placebo needle design methods which were involved in those RCTs:about50%of the disease is the main about the symptoms of pain, such as chronic low back pain, chronic neck and shoulder pain, headaches, and acupuncture treatment for the disease symptoms of pain, like osteoarthritis, temporomandibular joint disorders, rheumatoid arthritis. An additional50%of the acupuncture treatment of disease has nothing to do with the pain such as tinnitus, allergic rhinitis, hypertension, primary insomnia and perimenopausal syndrome. The highest frequency of placebo acupuncture design method was non-penetrated needle at true acupoints (36.99%), followed by superficial needling at non-acupoint (28.77%) in pain disease. The highest frequency of placebo acupuncture design method was superficial needling at non-acupoint (19.70%), followed by non-penetrated needle at true acupoints (18.18%)and deep needling at non-acupoint pain disease(16.70%) in non-pain-like disease.
1.2The analysis results of literature related to pain disease show that: according the different stimulus site of placebo needle, the percentage of placebo needle at true treatment acupoints to obtain a positive outcome was62.5%, The percentage of placebo acupuncture at non-therapeutic points group (total) made positive outcomes was51.22%and55.88%for non-acupoint placebo acupuncture group. The percentage of placebo acupuncture in pain source remote area to get a positive outcome was61.11%, and54.55%for pain source proximal placebo acupuncture group. According to the different categories of needling depth, the percentage of non-penetrated placebo needle to obtain a positive outcome was67.86%, The percentage of penetrated placebo acupuncture made positive outcomes was48.89%and51.85%for shallow placebo acupuncture group. The percentage of deep inserted placebo acupuncture to get a positive outcome was44.44%.
1.3The analysis results of literature related to non-pain-like disease show that: according the different stimulus site of placebo needle, the percentage of placebo needle at true treatment acupoints to obtain a positive outcome was57.14%, The percentage of placebo acupuncture at non-therapeutic points group (total) made positive outcomes was67.31%and61.11%for non-acupoint placebo acupuncture group. According to the different categories of needling depth, the percentage of non-penetrated placebo needle to obtain a positive outcome was52.00%, The percentage of penetrated placebo acupuncture made positive outcomes was73.17%and78.95%for shallow placebo acupuncture group. The percentage of deep inserted placebo acupuncture to get a positive outcome was68.18%.
2. Result of research on the factors influencing acupuncture effect under different disease states
The study included two parts, that was electro-acupuncture treatment research and needle acupuncture research. According to types of diseases each part can be divided into pain disease research and non-pain-like disease research. according to feature selection algorithm CfsSubsetEval were drawn the indicators of most discrimination between all the treatment group and the control group of the study, which is considered to be the the key factors influence the acupuncture effect.
2.1Analysis on EA study of literature related to pain showed that:the most discriminative indicators between the treatment group and the control group are as follows:techniques, needling depth, the technique frequency, site of acupuncture, electro-acupuncture waveform;
2.2Analysis on EA study of literature related to non-pain showed that:the most discriminative indicators between the treatment group and the control group are as follows:techniques, site of acupuncture, electro-acupuncture waveform, the technique frequency, depth of acupuncture, electro-acupuncture frequency;
2.3Analysis on acupuncture study of literature related to pain showed that:the most discriminative indicators between the treatment group and the control group are as follows:techniques, technique frequency, needling depth, technique magnitude, site of acupuncture;
2.4Analysis on acupuncture study of literature related to pain showed that:the most discriminative indicators between the treatment group and the control group are as follows:site of acupuncture, technique frequency, technique amplitude, needling depth, technique;
3. Observation on inhibition effect of rat C-fiber reflex with different stimulus intensities at different puncture sites:
3.1Experimental results of C-fiber reflex inhibition effect on EA at different parts with the different stimulus intensity of rat show that:weak stimulation (0.6Tc) at the same side of the same segment caused a strong inhibitory effect on the C-fiber reflex (P<0.05, P<0.01); The C-fiber reflex inhibition effect is not obvious (P>0.05) with weak stimulation (0.6Tc) at Shousanli in remote different segments or contralateral Zusanli in ectopic same segment. When electrical stimulation intensity the strong (Tc/1.5Tc), whether Zusanli on the same side of the same segment, Zusanli on contralateral side of ectopic same segment, or Shousanli in the distal the different nerve segment,there will be a strong inhibitory effect on the C-fiber reflex(P<0.01); With increasing stimulus intensity at the same stimulus site, the inhibitory effect on the C-fiber reflex also will be enhanced (P<0.01); With the same stimulus intensity, for the acupoint and the non-acupoint next to it, the inhibitory effect on the C-fiber reflex has no significant difference (P>0.05).
3.2Experimental results of C-fiber reflex inhibition effect on acupuncture at different parts with the different stimulus intensity of rat show that:weak stimulation (superficial needling without stimulation) at the same side of the same segment caused a strong inhibitory effect on the C-fiber reflex (P<0.05, P<0.01); The C-fiber reflex inhibition effect is not obvious (P>0.05) with weak stimulation (superficial needling without stimulation) at Shousanli in remote different segments or contralateral Zusanli in ectopic same segment. When stimulation intensity the strong (deep needling/deep needling+twisting), whether Zusanli on the same side of the same segment, Zusanli on contralateral side of ectopic same segment, or Shousanli in the distal the different nerve segment, there will be a strong inhibitory effect on the C-fiber reflex(P<0.01); With increasing stimulus intensity at the same stimulus site, the inhibitory effect on the C-fiber reflex also will be enhanced (P<0.01); With the same stimulus intensity, for the acupoint and the non-acupoint next to it, the inhibitory effect on the C-fiber reflex has no significant difference (P>0.05).
Conclusion
1.Due to the special nature and complexity of the clinical research of acupuncture treatment, the placebo needle effect can not be equivalent to the placebo effect, from the perspective of placebo acupuncture setting method of the RCTs in pubmed database, placebo needle can be seen as the special form of acupuncture treatment,when the effects of acupuncture treatment effect is most minimal, it can be used as a the ideal placebo acupuncture;
2. As a special form of acupuncture treatment, factors influencing acupuncture effects is equally applicable to placebo needle effects. In various disease states factors affecting acupuncture effect results showed that in different disease states, stimulus location and intensity have different influence on the acupuncture effect. So when the placebo needle is designed, the acupuncture site and needling depth should not only be considered, different disease states should also be taken into account;
3. Result of experiment study on the factors that affect the placebo needle effect of pain disease indicates that:the effect of placebo acupuncture of pain disease mainly depends on the stimulus intensity, and the relative position of the acupuncture site with the source of the pain. When the site of stimulation and pain source in the same nerve segment, regardless of the weak stimulation or strong stimulation can both produce analgesic effect; strong stimulation can produce analgesic effect when the site of stimulation and pain source are in the different remote nerve segment Therefore, the ideal placebo acupuncture design for pain disease should be weak stimulation at point far away from the pain source in the different nerve segment region.
Innovation points
This study of very important practical significance aims to explain how to apply internationally accepted clinical epidemiology and evidence-based medicine method to make objective assessment of the efficacy of acupuncture from the point of view of placebo needle design, which can help acupuncture therapy at home and abroad be widely recognized and accepted.As an important part of the clinical evaluation of acupuncture efficacy, research on the key factors that affect the placebo needle effect is a ground-breaking significance study. The innovation points are as follows:
1.Placebo needle can be seen as the special form of acupuncture treatment from the perspective of placebo acupuncture setting method, when the effects of acupuncture treatment effect is most minimal, it can be used as a the ideal placebo acupuncture.
2. As a special form of acupuncture treatment, factors influencing acupuncture effects is equally applicable to placebo needle effects.
3. The effect of placebo acupuncture of pain disease mainly depends on the stimulus intensity and the relative position of the acupuncture site with the source of the pain.
引文
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