ACUPUNCTURE CREDIBILITY SCALE SCORES ASSOCIATED WITH TCM ACUPUNCTURE VERSUS A SHAM ACUPUNCTURE PROCEDURE:IMPLICATION FOR CLINICAL TRIAL DESIGN

Objective: To compare self-reported perceptions of the credibility of traditional Chinese medicine(TCM) acupuncture and a shallowneedling sham procedure, and to explore whether study subjectscan distinguish between real acupuncture and sham acupuncture in controlled clinical trials for headache when they are exposed to both.Methods: Thirty-seven patients with frequent headaches and no prior experience with acupuncture received both a TCM acupuncture treatment and a sham acupuncture procedure in random order.Study participants were not informed that one of the treatments was intended to be a sham procedure.The main outcome measure was patient-perceived credibility of each procedure as assessed by the Acupuncture Credibility Scale.Results: The TCM acupuncture treatment was associated with mean credibility scale scores of 21.2(SD=4.0), whereas the sham acupuncture procedure was associated with a mean scale score of 19.6(SD=4.6).The difference in mean scores associated with the two protocols was 1.6(95% CI: 0.6-2.6; P=0.002).Mean credibility scale scores increased from the first to second treatment for TCM acupuncture, but decreased for the sham acupuncture procedure.Conclusion: The clinical significance of a 1.6-point difference on a 30-point scale is unclear, but the observation that study participants may be able to distinguish between TCM and sham acupuncture protocols after a single exposure to each provides support for the policy of excluding patients with prior experience with acupuncture from participation in clinical trials that involve a sham acupuncture control.     

ANALYSIS OF THE SHAM AND VERUM ACUPUNCTURE TECHNIQUES EMPLOYED IN THE ACUPUNCTURE RANDOMIZED TRIALS FOR TENSION TYPE HEADACHE:A REEVALUATION OF THE THEORETICAL BASIS AND LOGIC FOR ACUPUNCTURE PRACTICE AND RESEARCH

Analysis of the sham and verum acupuncture techniques employed in the acupuncture randomized trial for tension type headache: a reevaluation of the theoretical basis and logic for acupuncture practice and research.A number of research studies over the last decade have suggested that sham acupuncture technique may be as efficacious as true acupuncture.These findings are apparently at odds with traditional theories regarding acupuncture point specificity and needling technique and call into question someideas which are commonly held by many practicing acupuncturists.These research results were identified as one of the "provocative paradoxes" or special research challenges at the 2007 SAR Conference marking the 10 th anniversary of the 1997 United States National Institutes of Health Consensus Conference on Acupuncture.In this paper, the author examines the sham and verum technique used in the 2005 German Acupuncture Randomized Trial for Tension Type Headache, one of the most often cited of these provocative research studies.The author applies a detailed evaluation of traditional Chinese acupuncture theory and a review of historical literature on theory and clinical practice.This analysis explains and demonstrates that the presumed sham technique, which was employed in this important clinical trial,in fact utilized an acupuncture approach that was theoretically as well suited as the named verum technique to treat the clinical problem under study.This paper's analysis serves as the foundation for a reevaluation of the theoretical basis and logic for acupuncture practice and research.The use of placebo in acupuncture research is examined and the application of comparative effectiveness trials as the most appropriate format for acupuncture research is proposed.     

FACTORS THAT MAY CONTRIBUTE TO THE INSTANT ANALGESIC EFFECTS OF ACUPUNCTURE FOR PRIMARY DYSMENORRHEA IN CLINICAL RANDOMIZED TRIALS

Objective: There are a great many variables in acupuncture treatment(e.g., point selection, the number of points selected, Chinese medicine patterns, acupuncture manipulation, different intervention time of acupuncture, duration of needling, number and frequency of sessions and needling sensation), all of which need to be addressed in designing and reporting clinical trials.We aim to find the factors that may affect the instant analgesic effects of acupuncture on primary dysmenorrhea in randomized controlled trials(RCTs).Methods: We reviewed factors involved in RCTs in three systematic reviews about acupuncture for primary dysmenorrhea.Results: The overall findings of this literature review suggested that the durations of needling in most RCTs lasted for 20-40 min, and the number and frequency of sessions were likely to last for 5-7 d and continued for three sessions.However, those variables of stimulation including point selection, number of points used, Chinese medicine pattern, acupuncture manipulation and different intervention time of acupuncture were particularly diverse from each other in treatment for primary dysmenorrhea.Conclusion: Our findings reinforce the understanding of acupuncture as a complex intervention.To identify how each component contributes to the instant analgesic effect, well-designed trials comparing those interventions head to head would be a practical and realistic approach to establish optimally effective acupuncture for primary dysmenorrhea.Few rigorous studies have compared the relative efficacy of different acupuncture treatment components within their protocols.Conclusive agreement on those parameters supporting the optimal treatment for patients has not been achieved.Due to the poor quality of available evidence shown in current statues, controlled comparative studies looking at every relevant variable of treatment for primary dysmenorrhea ought to be paid more attention, which may help clinical trials to improve transparency and standardize treatment efficacy.     

Blinding in acupuncture research: a systematic review of randomized controlled trials for pain using a sham acupuncture control

Objective: To study the various methods and levels of blinding in acupuncture research. Data sources: Reference lists of the most recent systematic review of acupuncture on pain, systematic search of MEDLINE from 1966 to August 2000, CINAHL from 1982 to August 2000, and HealthSTAR from 1975 to August 2000.Study selection: Randomized studies were included if they evaluated the effectiveness of acupuncture in painful conditions using a blinded design.Data extraction: The hard copy of each of the eligible studies available was reviewed. The following information was extracted: name of first author, publication year, study design, blinding testing, treatment sham group received, and the outcome measures.Data synthesis: There were 19 studies identified. They were described as ‘double blinded’ by the authors, referring to blinding of patients and evaluators. Sixteen studies did not perform any blinding testing after the treatments were over. Only three studies provided information that the blinding of patients was successful. These three studies used different questionnaires to assess the success of blinding. There was no study that evaluated the success of blinding of treatment evaluators. Also, no study attempted blinding of the treating acupuncturists.Conclusions: Proper blinding of patients and evaluators is possible in acupuncture research and many different techniques of proper blinding exist. Assessment of blinding is a critical aspect of any sham or placebo controlled trial and should be routinely incorporated into the design of such trials of acupuncture.     

SUBJECTS' BELIEF IN TREATMENT ALLOCATION CAN VARY BY TYPE OF ACUPUNCTURE:THE CASE OF IBS

technique for blinding acupuncture clinical trials.The literature on the validation of these devices is mixed however and may vary on how the question is asked.We conducted a single-blind placebo-controlled RCT(n=289) with irritable bowel syndrome(IBS) patients randomized to one of three contexts: augmented(e.g., warm, attentive, confident practitioner), limited(e.g., minimal communication), or waitlist for three weeks.Both treatment arms in this first three weeks received biweekly non-insertive/sham placebo acupuncture.At week 3, treatment group subjects were re-randomized to receive either insertive/verum or continue on non-insertive/sham acupuncture for treatment weeks 3-6.Results comparing treatment groups across the first three weeks showed that the augmented context participation was significantly related to symptom reduction.Analyses considering the efficacy of adding needle insertion in weeks 3-6 showed a trend toward the added benefit of insertive acupuncture.We measured subject blinding in two ways:(1) Prompted(with single question after the 1st, 5th, 7th, and last acupuncture treatments) with the question: "How confident do you feel that the acupuncture treatment that you received is a true treatment?"(2) Unprompted(practitioners noted in the patient chart if subjects reported any new sensations in the visit following re-randomization in Phase II; practitioners were also asked to note what the reported change was).Differences in mean prompted blinding measurement score in Phase II were compared by treatment group using ANOVA, and type of acupuncture administered(real vs.sham) was found to be significantly related to level confidence in "true treatment" to significance level P0.05.Unprompted blinding measurement results are displayed as simple tabulations.     

CHARACTERISTICS OF RANDOMIZED CLINICAL TRIALS ON ACUPUNCTURE REGISTERED IN TRIAL REGISTRIES:A SYSTEMATIC ANALYSIS

Objective: To systematically analyze the characteristics of randomized clinical trials on acupuncture registered in major international trial registries and to evaluate trial methodological quality.Methods: Fifteen trial registries were searched to identify randomized clinical trials on acupuncture.Methodological quality of each registered trial was assessed using the Cochrane risk of bias tool including generation of allocation sequence, allocation concealment and blinding.Results: A total of 523 randomized trials were registered, of which 324 were registered after recruitment of the first participant.The number of registered acupuncture trials increased from 2 in 1999 to 83 in 2012.Majority of the trials were single-center(72.8%), parallel-group(76.7%), two-arms(67.7%), placebo/sham-controlled(52.0%), and funded by university, government or hospital(84.7%).The most frequent conditions were musculoskeletal(23.3%), nervous(12.1%), mental and behavioral disorders(10.5%), digestive(7.3%), and genitourinary(6.7%).The mostfrequently reported acupuncture components was treatment regimen(54.6%), followed by details of needling(45.7%), other interventions administered with acupuncture(23.3%), style of acupuncture(17.6%), and practitioner qualification(7.5%).Detailed information on randomization was obviously insufficient.For example, 85.5% lacked information on generation of allocation sequence, 93.1% did not provide details on allocation concealment.Of 339 trials using blinding, 23.5% applied blinding to participants, 4.6% applied blinding to both participants and personnel, and 5.4% reported blinding to participants, personnel and outcome assessors.More than two thirds of the trials reported primary and secondary outcomes, but only 14.7% and 2.3% reported safety outcome and health-economics outcome, respectively.Conclusion: Increasing number of clinical acupuncture studies have been registered in international trial registries.The study design of registered acupuncture trials has been improved in use of blinding.However, the methodological information in the registered acupuncture trials is insufficient, and the Standard Protocol Items for Randomized Trials should be followed.     

基于CONSORT与TIDieR-Placebo评价安慰针刺治疗膝骨性关节炎随机对照试验文献的报告质量*

目的：评估针对膝骨性关节炎治疗中安慰针刺的随机对照试验（RCT）文献的质量,探讨安慰针刺临床试验设计的思路。方法：计算机检索中国期刊全文数据库（CNKI）、维普中文期刊全文数据数据库（VIP）、万方数据知识服务平台（WF）、中国生物医学文献数据库（SinoMed）、PubMed、Web of Science（WOS）及Embase数据库,收集使用单纯针刺与安慰针刺进行对比的针灸治疗膝骨性关节炎RCT研究,检索时限从建库至2022年12月31日。使用CONSORT与TIDieR-Placebo标准评估文献报告质量,并对结果进行分析讨论。结果：共纳入20篇文献。CONSORT评价结果显示报告率不高于10%的条目为条目3b、 6b、11b、12b、14b、17b、18。TIDieR-Placebo评价结果显示报告率不高于10%的条目为条目6、9、10、11、13。安慰针刺的方式主要为“假穴假刺”“假穴真刺”“假穴浅刺”“非治疗穴真刺”“治疗穴假刺”5种。结论：有关安慰针刺的临床试验尚不严谨,质量有待提高。为推动针灸领域临床研究的标准化,建议未来的研究应更加重视依据这些标准来规范化研究报告。     

THE PROBLEMS AND COUNTERMEASURES IN IMPLEMENTING RANDOMIZED PROTOCOL FOR ACUPUNCTURE CLINICAL STUDIES

Objective: Based on analyzing the randomized protocols and implementation of past acupuncture projects, this paper would figure out the problems and provide countermeasures to improve the randomization application in further clinical trials of acupuncture.Methods: Seventeen acupuncture projects using a central randomized computer system for treatment assignment were selected In order to identify the complexity of randomized protocols, this paper analyzed the indicators for the above projects.Results: In these 17 projects, the mean number was 436 for sample size.The average number for groups was three, and the maximum number was nine.A site-stratified block method was used in 15 studies, which means each group had equal sample sizes for different sites.However, in another two projects using sample randomized method, the sample size ratio for groups had not satisfied with the projects' protocols and the mean unequal rate among different groups were 15.72% and 14.01%, respectively For all these 17 projects, sometimes more than one randomized number were misused to same subject by clinical researchers because of error operation, and the mean misused number per project was 3.Two randomized protocols were adjusted duringimplementation.Less error case allocation existed in 8 projects(47%) using the disorder-randomized method than the other 9 projects using sequential-order-randomized method, and the mean error case allocations for the above two groups were one and two cases, respectively.Conclusion: Randomized, controlled and open-label design is usually used in acupuncture clinical trials.The trial group number is always more than that in drug clinical research.The disorder-randomized method could improve researchers' compliance.Dynamically block design method or dynamic randomized algorithm(e.g., minimization method) could be used to avoid program adjustment during study implementation and unbalanced sample sizes among different comparison groups.     

EFFECTS OF ACUPUNCTURE ON ALLERGIC RHINITIS:A RANDOMIZED,CONTROLLED CLINICAL TRIAL

Objective: To assess the effects of acupuncture on allergic rhinitis in a randomized, controlled clinical trial.Methods: This study was a multicenter, randomized, parallelcontrolled study.Participants were randomized into active acupuncture, sham acupuncture, or waitlist groups.The active and sham acupuncture groups received acupuncture treatment three times per week for 4 weeks.In the sham group, minimal acupuncture at non-acupuncture points was used.The waitlist group did not receive any acupuncture treatment during the study.The clinical efficacy was assessed at every week after treatment.Results: Of the 98 participants, 40, 39, and 19 individuals were assigned to the active acupuncture, sham acupuncture, and waitlist groups, respectively.At baseline, the means of the total nasal symptom score(TNSS) were 6.76(SD: 3.31), 7.25(SD: 2.97), and 7.06(SD: 2.46), respectively.After 4 weeks of treatment, TNSS was significantly reduced in the active acupuncture and sham acupuncture groups compared to baseline.The changes of TNSS in the 2nd and 4th weeks from baseline in the active acupuncture group were significantly greater than the sham acupuncture and waitlist groups.In addition, the results showed that TNSS and the Rhinitis Quality of Life Questionnaire score had significant changes in the active acupuncture group compared with the sham acupuncture and the waitlist groups.Conclusion: Active acupuncture showed a significantly greater effect on symptoms of allergic rhinitis than sham acupuncture.Acupuncture is an effective and safe treatment for allergic rhinitis.     

Effects of trigger point acupuncture treatment on temporomandibular disorders: a preliminary randomized clinical trial

We compared the effects of trigger point acupuncture with that of sham acupuncture treatments on pain and oral function in patients with temporomandibular disorders (TMDs). This 10-week study included 16 volunteers from an acupuncture school with complaints of chronic temporomandibular joint myofascial pain for at least 6 months. The participants were randomized to one of two groups, each receiving five acupuncture treatment sessions. The trigger point acupuncture group received treatment at trigger points for the same muscle, while the other acupuncture group received sham treatment on the trigger points. Outcome measures were pain intensity (visual analogue scale) and oral function (maximal mouth opening). After treatment, pain intensity was less in the trigger point acupuncture group than in the sham treatment group, but oral function remained unchanged in both groups. Pain intensity decreased significantly between pretreatment and 5 weeks after trigger point (p<0.001) and sham acupunctures (p<0.050). Group comparison using the area under the curve demonstrated a significant difference between groups (p=0.0152). Compared with sham acupuncture therapy, trigger point acupuncture therapy may be more effective for chronic temporomandibular joint myofascial pain.     

2000年—2011年针刺治疗原发性痛经临床研究的对照设置概况

合理的对照设置在针灸临床研究中具有重要作用,笔者通过对2000年—2011年间国内外发表的针刺治疗原发性痛经临床研究的对照设置情况进行分析总结,发现国内文献(111篇)中近半数未设置对照组,对照研究则主要采用西药对照;国外文献(13篇)均设置了对照组,主要采用空白及安慰对照。笔者认为国内研究者可借鉴国外常用对照设置方法,根据研究目的选择合理的对照措施,从整体上进一步提高针刺治疗原发性痛经的临床研究水平。     

国外假针刺对照的针灸临床试验研究现状分析

对国外开展的假针刺对照的针灸临床试验研究进行总结梳理,包括:1假针刺的概念背景,2假针刺对照的针灸临床试验在各国的发展现状,3德国假针刺对照的针灸临床试验研究概况,4国外大样本针灸临床试验中关于假针刺对照试验的研究概况。对假针刺对照试验的未来发展趋势进行总结分析,提出目前针灸研究存在的问题。     

Exploring practice characteristics and research priorities of practitioners of traditional acupuncture in China and the EU-A survey

Ethnopharmacological relevance

Acupuncture practice is based on the theoretical, historical and philosophical principles, which are part of Chinese medicine. Traditional acupuncture practitioners assess their patients’ conditions using Chinese medicine diagnostic techniques, which determine clinical care and treatment. Little is known about differences in the perceptions of research evidence among practitioners in the European Union (EU) and China, given the diversity of acupuncture practice.

Material and methods

This study explored differences between practitioners of traditional acupuncture regarding perceived need for research evidence and prioritisation for future clinical trials, based on their practice within the EU and China.A convenience sample of acupuncturists in the EU (contacted by their professional organisation) and China (from geographically dispersed hospitals) were invited to participate in a survey, which was conducted during 2010/2011. Data collected included: practitioners’ demographic details, country of training, practice setting, acupuncture techniques, perceived adverse event reporting, diagnostic methods, conditions commonly treated, conditions perceived as needing more evidence and practitioner perceptions of conditions which could demonstrate benefit if investigated in clinical trials.

Results

From 1126 survey responses, 1020 (559 EU, 461 China) could be included in the analysis for direct comparison. A response rate for the EU could not be calculated but for China was 98%. Pain was the most frequently reported commonly treated condition by EU acupuncturists and neurological conditions (mainly stroke) for Chinese practitioners. The top reported priorities for research were obstetrics/gynaecological conditions in the EU and neurological problems in China.

Conclusion

The survey identified differences in practice and training between acupuncturists in China and the EU and between EU member states. These differences may inform prioritisation of health conditions for future trials. Innovative research methods are recommended to incorporate the complexity and plurality of acupuncture practice and theory. Creation of collaborative networks is crucial in overcoming these differences to facilitate international, multi-centre clinical trials.     

RANDOMIZED CLINICAL TRIALS ON ACUPUNCTURE PUBLISHED IN CHINESE JOURNALS:A SYSTEMATIC LITERATURE REVIEW

Objective: To systematically evaluate the number and quality of randomized clinical trials(RCTs) on acupuncture published in Chinese journals.Methods: We systematically searched the four main electronic Chinese databases(CNKI, VIP, CBM, Wanfang) from their inception in January 2013 to identify RCTs on acupuncture(including manual and electronic acupuncture), to bibliometrically analyze the RCTs, and to assess methodological quality of the RCTs.Results: A total of 7085 RCTs(involving 698540 participants) were published from 1982 to 2013 in Chinese literature.The top three disease systems identified in the included trials were nervous system(39.5%), musculoskeletal system and connective tissue(21.3%), and genitourinary system(6.2%) according to ICD-10.The 7085 acupuncture trials were compared with no treatment(51 trials, 0.7%), sham-acupuncture(62 trials, 0.9%), conventional treatment(728 trials, 10.3%), other traditionalChinese medicine(911 trials, 12.9%), as well as acupuncture plus conventional treatment versus conventional treatment(946 trials, 13.4%), acupuncture plus one treatment versus another treatment(1493 trials, 21.7%), acupuncture plus one treatment versus acupuncture alone(915 trials, 12.9%).In addition, 1135 trials(16.0%) were two-armed RCTs, in which acupuncture applied in both groups.A total of 844 trials(11.9%) were three or more-armed RCTs.Forty-two trials(0.6%) of 7085 RCTs clearly defined primary and secondary outcomes, 6803(96.0%) reported clinical relevant outcomes, 659(9.3%) reported surrogate outcomes, 497(7.0%) reported safety outcomes.For methodological quality, 2658(37.5%) RCTs reported randomization methods, 121(1.7%) reported allocation concealment methods, 141(2.0%) applied blinding, and only 28(0.4%) described sample size calculation.Conclusion: The number of RCTs on acupuncture was substantial and increasing in China, and acupuncture was most frequently applied to nervous, musculoskeletal and connective tissue diseases.However, the methodological quality of the trials is still low.We recommend that the reports of future RCTs on acupuncture will be based on CONSORT and STRCTA.     

针刺治疗中风后痉挛性瘫痪的系统评价

对针刺治疗中风后痉挛性瘫痪的随机对照试验(RCT)或半随机对照试验(quasi-RCT)按Cochrane协作网推荐的方法进行系统评价.14篇中文文献978例患者满足纳入标准,但均为低质量试验.纳入的9个试验进行Meta分析结果显示:Ashworth评分、Carr-Shepherd运动评分、神经功能缺损程度评分、髋内收肌张力评分中试验组和对照组均无差别,而Fugel-Meyer评分中1项研究、Barthel指数评分中3项研究试验组优于对照组.由于纳入研究数量和质量上的缺陷,尤其是缺乏远期功能性结局指标,虽显示针刺有改善中风后痉挛性瘫痪的趋势,无不良反应,但目前尚不能对其疗效得出肯定结论,因此开展更多高质量、多中心的RCT非常必要.     

ASSESSMENT OF THE QUALITY OF REPORTING FOR TREATMENT COMPONENTS IN COCHRANE REVIEWS OF ACUPUNCTURE

Objective: High-quality reporting of treatment details can aid replication of study results in real-world clinical practice.The Standards for Reporting Interventions in Clinical Trials of Acupuncture(STRICTA) is a reporting guideline for key elements of acupuncture interventions in clinical trials.This study used STRICTA to investigate whether Cochrane reviews of acupuncture adequately report important treatment details.Design: Systematic review methods: Cochrane reviews of acupuncture were identified from The Cochrane Library(Issue 7, 2012).Randomized controlled trials(RCTs) included in the reviews and published after 2005 were obtained.Using STRICTA, we extracted acupuncture-related information from both the Cochrane reviews and the RCTs.The characteristics of included studies table were the major source of intervention information from Cochrane reviews.Reporting quality of acupuncture interventions in Cochrane reviews was assessed and compared to the respective RCTs.Results: Twenty-five Cochrane reviews of acupuncture and 92 RCTs met the selection criteria.Cochrane reviews were 16% less likely to report the acupuncture-related items of STRICTA than RCTs(risk ratio 0.84, 95% confidence interval 0.79 to 0.88, I2=8%).Information was significantly better reported for 10 of the 15 treatment-group items of STRICTA in RCTs than in Cochrane reviews(P0.05), while four items did so without statisticalsignificance.One item related to practitioner background was significantly better reported in Cochrane reviews.Conclusion: Reporting quality of treatment details in Cochrane reviews of acupuncture was insufficient with regard to STRICTA, even though such information was readily reported in RCTs.The overall quality of reporting of the RCTs, while better than the reviews, was also often suboptimal.Use of STRICTA guideline during the review process is recommended to adequately report the key treatment components in Cochrane reviews of acupuncture.The potential impact of STRICTA to the replicability and utilization of reviews in future research and practice needs to be investigated.     

Efficacy of acupuncture on fibromyalgia syndrome：a Meta-analysis

OBJECTIVE：To comprehensively evaluate the effectiveness of acupuncture as a treatment for fibromyalgiasyndrome.METHODS： Two review authors independently selected the trials for the Meta-analysis, assessed their methodological quality and extracted relevant data. A quality assessment was conducted according to the Cochrane Review Handbook 5.0.RevMan 5.0.20 software was used in the statistical analysis.RESULTS： A total of 523 trials were reviewed and 9trials were selected for Meta-analysis.（a） Compared acupuncture with sham acupuncture, there was a significant difference in the visual analogue scale,but no difference in the pressure pain threshold.Additionally,and there was a difference in the fibromyalgia impact questionnaire and the multidisciplinary pain inventory after 4 weeks of treatment,but no difference after 7 weeks of therapy. There was no difference in the numerical rating scale in weeks 3, 8 and 13.（b） Acupuncture versus drugs.There were differences in the VAS after 20 days of acupuncture and moxibustion treatment comparing with the drug amitriptyline, and after 4 weeks of acupuncture and moxibustion treatment comparing with the drug fluoxetine and amitriptyline.There were also differences in the number of tender points when comparing acupuncture with amitriptyline or fluoxetine. There was no difference in total efficiency when comparing acupuncture with amitriptyline after 4 weeks of treatment, but there were differences between the two groups 45 days after treatment.There were also differences in total efficiency comparing acupuncture with fluoxetine,and when comparing 4 weeks post-treatment of acupuncture with a combination of amitriptyline,oryzanol and vitamin B.（c） A comparison of acupuncture, drugs and exercise with drugs and exercise showed PPT differences in months 3 and 6.There was no difference between the two comparison groups after follow-up visits in months 12 and 24.CONCLUSION： Compared with sham acupuncture,there was not enough evidence to prove the efficacy of acupunc     

“醒脑开窍”针刺法对照非经穴点的设立——经穴特异性临床研究的方法探讨

在针刺临床随机对照实验(RCT)中,对其有效性、安全性以及技术特性的评估,要以正确严谨的取穴方法和设立科学合理的非穴点安慰对照为前提.建立醒脑开窍针刺组及其非经穴点对照组模型,实施干预措施,鉴别获取参数的差异,评价临床疗效,从而观察处理因素的真实性.