HERB-PARTITIONED MOXIBUSTION AND ACUPUNCTURE FOR THE TREATMENT OF ACTIVE CROHN'S DISEASE:A RANDOMIZED CONTROLLED TRIAL

Background: Acupuncture and moxibustion are often used as an alternative therapy for Crohn's disease(CD), however, their efficacy are not fully established.Objective: This study sought to evaluate the clinical efficacy and safety of acupuncture and moxibustion for the treatment of active CD of mild to moderate severity.Methods: Ninety-two patients were equally and randomly divided into a treatment group that received herb-partitioned moxibustion combined with acupuncture and a control group that received wheat bran-partitioned moxibustion combined with shallow acupuncture.The patients received 3 treatment sessions per week for 12 weeks, and were followed up at the 24 th week.The outcomes were measured by using the CD Activity Index(CDAI) score, lab tests, endoscopic rating, and intestinal histology.Results: The CDAI scores of both the treatment and control groups were significantly reduced after treatment compared to that prior to treatment, but the improvement of the treatment group was significant better than that of the control group.The symptom improvement in patients of the treatment group was sustained at the follow-up, while that of the control group was not.Both groups showed significantly improvement in quality of life ratings after treatments, but the improvement was significantly better in the treatment group than in the control group.In addition, the patients in the treatment group showed significantly increased hemoglobin and decreased C-reactive protein and histopathological scores at the end of the treatment, while the control group did not show any changes.Conclusion: Acupuncture and moxibustion are effective and safe treatment methods for mild to moderate CD.In addition to the placebo effect, acupuncture also has significant therapeutic effects.     

USE ACUPUNCTURE TO TREAT FUNCTIONAL DYSPEPSIA:STUDY PROTOCOL OF A RANDOMIZED CONTROLLED TRIAL

Objective: The problem of whether acupuncture is efficacious for patients with functional dys pepsia is still controversial, so we designed a randomized controlled trial to settle the problem.Design: We designed a multicenter, two-arm, sham-controlled clinical trial.Two hundred participants with functional dyspepsia will be randomly assigned to true acupuncture(TA) group and sham acupuncture(SA) group in a 1:1 ratio.Participants in the TA group will receive acupuncture at points selected according to syndrome differentiation.Participants in the SA group will receive penetrations at sham points.Participants in both groups will receive 20 sessions of electroacupuncture for 4 weeks, 5 times continuously with a 2-day rest in a week.The primary outcome is the proportion of patients reporting absence of dyspeptic symptoms at 16 weeks after inclusion.The secondary outcomes include Short-Form Leeds Dyspepsia Questionnaire(SF-LDQ), Chinese version of 36-Item Short Form Survey(SF-36), Chinese version of Nepean dyspepsia index(NDI), etc.Discussion: The result of this trial is hopefully to be gained on August, 2014, which would possibly answer the question of whether acupuncture is efficacious for patients with functional dyspepsia.     

EFFICACY OF ACUPUNCTURE FOR MOTION SICKNESS:A RANDOMIZED CONTROLLED CLINICAL TRIAL

Objective: In this randomized, controlled study, we observed the efficacy of acupuncture in motion sickness.Methods: We did a randomized and controlled trial of acupuncture in volunteers with motion sickness.A total of 60 patients were randomly assigned to acupuncture or standard care group.The acupuncture group received treatments on acupuncture points including GV20(Baihui), EX-HN1(Sishencong), bilateral PC6(Neiguan) and ST36(Zusanli), twice per week for 5 weeks.The control group received only usual care during the same period.The two experimental groups received tests with motion sickness device in the same environment.Graybiel score and the degrees of discomfort were used to evaluate the degree of motion sickness.Car trials were used for the evaluation of clinical efficacy.Analysis was performed on the last score except patients who were dropped out before completion.Results: The Graybiel scores were 10.12±3.37 and 9.95±2.60 in the acupuncture group and the control group respectively with no significant difference(P0.05) before treatment.The Graybiel scores were 0.92±0.40 and 9.86±2.53 in the acupuncture group and the control group respectively with significant differences(P0.05) after treatment.The motion sickness degree distribution in the acupuncture group was N, 0;I, 0; IIB, 0; IIA, 7; III, 16; and F, 2 before treatment; and N, 3; I, 22; IIB, 0; IIA, 0; III, 0; and F, 0 after treatment.The distribution of the control group was N, 0; I, 0; IIB, 0; IIA, 5; III, 16; and F, 1 before and after treatment.After the experiment, the degrees of discomfort in the acupuncture group significantly decreased(P0.01).Total effective rates of the acupuncture group and the control group were 96% and 0% respectively with significant differences(P0.05).No adverse effects of acupuncture were reported.Conclusion: These data suggest that acupuncture is an effective therapy for patients with motion sickness.The anti-motion sickness capabilities are improved and the sufferings of patients with motion sickness were alleviated after acupuncture treatment.     

ACUPUNCTURE FOR CORONARY HEART DISEASE WITH DEPRESSION:STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL

Objective: Coronary heart disease(CHD) is a chronic condition, which seriously affects the daily lives of patients.In the course of CHD, depression can adversely affect the patient's heart condition.Mitigating the depressive state in patients has great benefit to improve the patients' condition of CHD.Acupuncture can relieve depression as well as medicines.However, its effect for CHD with depression is inconclusive.Aim of this study is to evaluate acupuncture for CHD patients with depression in China.Methods: The study is a prospective randomized controlled trial comparing the effects of acupuncture with placebo needle.Patients are manual-based, follow clinical epidemiology and acupuncture clinical practice criterion, and share evidence-based medicine.Patients will be randomly assigned to the acupuncture group and the placebo needle group, and acupuncture doctors with clinical practice experience will carry out the intervention.Data will be collected at baseline and 4, 8, 12, and 16 weeks after intervention.The evaluation indicators are Seattle angina questionnaire for patients' changes in the quality of life and Zung's self-evaluating depression scale for their mental changes.The recruitment will be completed in September 2014.Discussion: We expect that patients' depression condition after acupuncture will be mitigated significantly compared with the placebo needle group, and the quality of life of patients after acupuncture will be improved significantly than the placebo needle group.We estimate that the acupuncture has a benefit effect to mitigate the depression state of CHD patients, and to improve the quality of their life.The study will provide a new non-drug therapy for CHD with depression, by improving the patient's mental state to improve their quality of life.     

EVALUATION ON THE THERAPEUTIC EFFECT OF DEEP PUNCTURE OF TIANSHU (ST 25) FOR SLOW TRANSIT CONSTIPATION

Slowtransit constipation(STC),also called as“colonic inertia”,is thought to have a pri mary defectslower than normal movement of contents fromtheproxi mal to the distal colon and rectum.It belongs todysfunctional constipation and is mainly manifestedbylumpy or hard stools and decrease in the desire ofdefecation,someti mes,with concurrent abdominalpain and discomfort,etc.It constitutes about15%ofthe constipation patients[1]andis arefractory disease.The therapeutic effects of current remedies…     

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.     

ACUPUNCTURE FOR DRY EYE SYNDROME AFTER REFRACTIVE SURGERY:STUDY PROTOCOL FOR A RANDOMIZED CONTROLLED TRIAL

Background: Dry eye is a frequent consequence of refractive surgery.Acupuncture has been widely used to alleviate the associated symptoms.Nevertheless, the use of acupuncture for patients who suffer from dry eye syndrome following refractive surgery has its limits.This pilot study aims to evaluate the efficacy of acupuncture treatment in treating the signs and symptoms of dry eye after refractive surgery.Methods: Forty participants will be randomly assigned to acupuncture plus usual care group or usual care control group.While maintaining usual care, the acupuncture plus usual care group will undergo treatments 3 times per week for 4 weeks on 17 acupuncture points.The control group will receive only usual care during the same period.The primary outcome will refer to ocular surface disease index(OSDI) and examinations at 1, 3, 5, and 13 weeks.A tear-film breakup time(TBUT), the Schirmer-I test, visual analogue scale(VAS), quality of life(QOL) for selfassessment of ocular discomfort, and fluorescein-stained corneal surface digital photography will be used as secondary outcome variables.Schirmer-I test, TBUT, and fluorescein-stained corneal surface digital photography will be assessed at the screening and week 13.VAS will be assessed at the screening, and 1, 3, 5, and 13 weeks.QOL will be evaluated at 1, 3, 5, and 13 weeks.Discussion: This trial will provide primary data for the clinical effectiveness and safety of acupuncture treatment for dry eye after refractive surgery.     

MULTI-CENTER RANDOMIZED CONTROLLED TRIALS OF COMBINED TREATMENT OF VERTEBRAL ARTERY TYPE CERVICAL SPONDYLOSIS WITH ACUPUNCTURE AND MASSAGE

Vertebralarterytypecervicalspondylosis(VACS)isacommontypeofcervicalspondylosis(CS).Itisusuallymanifestedbyvertigoduetocer vicalretrogradedegenerationwhichimpairstheblood supplyfromvertebralarterytothebrainstemand labyrinthine.Amongtheremediesaimingtorelieve VACS,acupunctureandmassagearewell accepted worldwide.Duringthepasttwodecades,alarge numberofarticleswerepublishedinthisfield,and mostofthemshowedsatisfactorytherapeuticeffects.However,therearestillsomeflaws:1)poormethod ologicalqualityu…     

USING ACUPUNCTURE EXERCISE THERAPY TO TREAT PERIPHERAL FACIAL PARALYSIS:A RANDOMIZED CONTROLLED TRIAL

Objective: Acupuncture exercise therapy is a new and effective therapy for some nervous system diseases and motor system diseases.The problem that whether acupuncture exercise therapy is effective for patients with peripheral facial paralysis is still unclear.Therefore, we reported a randomized controlled trial of using acupuncture exercise therapy to treat peripheral facial paralysis.Methods: This was a randomized, controlled trial.A total of 302 patients were randomly allocated into acupuncture exercise group(AE, n=100), sham acupuncture and exercise group(SAE, n=101) and acupuncture group(AC, n=101).The AE group received needling at Zusanli(ST36), Hegu(LI4) and Fengchi(GB20) and the SAE group received needling at sham Zusanli(ST36), Hegu(LI4) and Fengchi(GB20).Patients exercised facial muscle, such as lifting eyebrow, mouth movement, and eye closure in the process of retaining needle for 30 min once a day.The AC group was treated with acupuncture at acupoints Sibai(ST2), Dicang(ST4), Jiache(ST6), Quanliao(SI18), Yangbai(GB14), Yingxiang(LI20) and Hegu(LI4) for 30 min once a day.The patients were treated continuously for 3 to 12 d.Patients were assessed weekly by blinded assessors, using the House-Brackmann facial nerve grading system.Results: The efficacy of the three groups was compared in terms of degree of recovery and speed of recovery.The overall improvement(grade 3 or better) was 90.1% in the AE group, 80.4% in the AC group and 78.5% in the SAE group.The degree of recovery and time of treatment in the AE group were significantly different from those in other groups(P0.05).However, the difference in the degree of recovery and time of treatment in the AC group and the SAE group was not statistically significant(P0.05).Conclusion: Acupuncture exercise therapy was effective to treat peripheral facial paralysis and exercise therapy played an important role in the course of acupuncture.     

IMMEDIATE EFFECT OF TWIRLING REINFORCINGREDUCING MANIPULATION ON ACUTE ISCHEMIC STROKE:A RANDOMIZED CONTROLLED TRIAL

Objective: To investigate the immediate effect of twirling reinforcing manipulation, twirling reducing manipulation and mild reinforcingreducing manipulation on motor functions in patients with ischemic stroke.Methods: Ninety patients with ischemic stroke were randomly divided into three groups by stratified blocked randomization.They were twirling reinforcing manipulation group(TRFM, n=39), twirling reducing manipulation group(TRDM, n=37) and mild reinforcing-reducing manipulation group(MRRM, n=40).Each group was treated in Baihui-Taiyang acupoint area.Neurological deficit score(NDS) and simplified Fugl-Meyer Assessment(FMA) were observed before and immediately after the treatment, and 1, 2 and 3 h after treatment.The results were analyzed by PASW statistics 18.0.Results: Score of FMA: The difference of FMA in the TRFMgroup was significant between pre-treatment and post-treatment(P0.05).FMA in the TRDM group and the MRRM group increased significantly at immediate time, and 1 and 2 h after treatment(P0.05), while no significant difference was found at 3 h compared with pre-treatment.FMA in the TRFM group was higher than that of the TRDM group and the TRRM group at immediate time, and 1 and 2 h after treatment(P0.05), but there was a difference at 3 h(P0.05).The statistical analysis showed that no significant difference was observed between the TRDM group and the TRRM group at all time points.Score of DNS: DNS in the TRFM group decreased sharply at immediate time, and 1, 2 and 3 h compared with pre-treatment(P0.05).DNS in the TRDM group and the MRRM group reduced at immediate time, and at 1 and 2 h(P0.05), while the difference at 3 h is not statistically significant compared with pre-treatment.DNS in the TRFM group was lower than that of the TRDM group and the TRRM group after treatment.Conclusion: TRFM has an advantage over TRDM and MRRM in immediate effect of motor functions of patients with ischemic stroke.     

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.     

ACUPUNCTURE FOR DYSPHAGIA AFTER CHEMORADIATION THERAPY IN HEAD AND NECK CANCER:A PILOT RANDOMIZED SHAMCONTROLLED TRIAL

Background: Dysphagia is a common side effect following chemoradiation(CRT) in patients with head and neck cancer(HNC).The purpose of this pilot trial was to assess the feasibility of recruiting HNC patients and to collect preliminary data on the efficacy and safety of acupuncture on dysphagia-related quality of life(QOL).Methods: Patients were eligible if diagnosed with stage IIIIV HNC, without evidence of distance metastasis, receiving curative-intent CRT.Patients were randomized to 12 sessions of either active or sham acupuncture, once every two weeks, over 24 weeks from during CRT to 20-week post-CRT.All study personnel and the patients were blinded, while the treating acupuncturists were not.MDADI and other questionnaires were measured at baseline(end of CRT), end of acupuncture, and at six months follow-up(12-month post-CRT).Data were analyzed by repeated-measures ANOVA adjusting for baseline.Results: Accrual was completed in December 2011.Among 42 patients enrolled, 35(83%) received at least 8 sessions of acupuncture, and 28(67%) received all 12.Six patients withdrew due to time constraints.No serious side effects were observed.The mean MDADI total scores improved from baseline in both treatment arms(64.5(SE±2.4) vs.71.4(SE±3.1), P=0.048; 64.5(SE±2.4) vs.77.8(SE±3.0), P0.001); the difference in improvement was not significant(P=0.12).The median feeding tube duration did not differ between active and sham treatments(n=39, median 125 d vs.147 d, P=0.93).Conclusion: Acupuncture is a safe and feasible treatment for HNC patients.In the pilot trial, improvements in QOL parameters from end of CRT to the time points examined were observed but they did not differ between the two arms.Efficacy of acupuncture to improve swallowing-related QOL in HNC patients may require more frequent or longer duration of treatment.     

电针丘墟穴治疗偏头痛多中心随机对照研究

目的：观察电针丘墟穴治疗偏头痛的疗效，为《中华人民共和国针灸穴典》提供丘墟穴主治偏头痛的临床研究资料。方法：采用了多中心（3家三甲临床医院）同时按照任务书的要求分别进行临床观察，以天枢穴为对照组，按照就诊的先后顺序查随机数字表进行分组，治疗组和对照组均采用电针方法，观察治疗组和对照组治疗前后的偏头痛各项临床症状指标和5-羟色胺（5-HT）。将所得数据，用SPSS11.5统计软件进行统计学处理与分析。结果：3所医院合并的两组患者VAS差值差别有显著性（u=-3．362，P=0．001）。3个临床中心和合并的两组患者4周疗效差别均有显著性，治疗组的效果好。第一、第三临床中心和合并的两组患者3个月疗效差别均有显著性，治疗组的效果好。第二临床中心的两组患者3月疗效差别无显著性。3个临床中心和合并的两组患者6个月疗效差别有显著性，治疗组的效果好。结论：电针丘墟穴治疗偏头痛是一种有效的方法。     

针刺对肾上腺髓质去甲肾上腺素细胞的作用及其作用途径的组化定量分析

<正> 近年来,对肾上腺髓质在镇痛与针刺麻醉过程中的作用曾有报导。但有关针刺对肾上腺髓质去甲肾上腺素细胞机能影响的研究尚属少见。本实验采用6-羟基多巴胺损坏去甲肾上腺素能节后交感神经纤维末梢的动物模型,并应用组化定量的方法,观察针刺对髓质去甲肾上腺素细胞的作用和分析其作用的所属途径。今将实验总结如下:     

针灸对免疫机能的调整功能

<正> 针灸治病的调整功能是多方面的,对免疫机能的调整是其中的一个方面,为了探讨针灸调整功能,本文从免疫学实验指标的变化,进行一些分析,现将所做细胞免疫和体液免疫两部分工作,整理报道如下: 一、针灸对细胞免疫的调整功能 1.淋巴细胞转化率测定:采用TC“199”液加PHA培养,收集细胞悬浮液,涂片染色,镜检计数,计算每个样品200个淋巴细胞,求出淋巴细胞转化率(％)。为了     

ASSOCIATION BETWEEN ACUPUNCTURE NEEDLING SENSATION(DE-QI) AND LOCAL SKIN BLOOD FLOW IN HEALTHY SUBJECTS:A SINGLE-BLIND,RANDOMIZED CONTROLLED TRIAL

Objective: De-qi refers to sensations generated by needle insertion into an acupuncture point.De-qi sensation is believed to be associated with treatment effects of acupuncture with the increase of local blood flow, although some patients may feel these sensations uncomfortable.This study aimed to assess the association between the strength of de-qi sensation and local skin blood flow in healthy subjects.Methods: Forty-five healthy subjects were randomized into real acupuncture(RA) group(n=15), Park-sham acupuncture(SA) group(n=15) and non-needling control(CO) group(n=15).A single acupuncture session was conducted on the right LI4 point with manual stimulation and 10-minute needle retention.De-qi sensation was assessed immediately after the removal of needling by the Southampton needle sensation questionnaire.Local skin blood flow recording within 2 cm in diameter of ipsilateral LI4 area was performed intermittently from just before the intervention to the end of the trial by the laser Doppler blood perfusion imager.Correlation between the change of skin blood flow and strength of De-qi was assessed.Results: Median change of local skin blood flow from baseline to post-treatment was 48.85, 48.20 and 0.59 arbitrary unit(AU) in RA, SA and CO groups, respectively.Median total sensation score was 10, 3 and 0 of 51 points, respectively.No significant correl ation between total sensation score and change of skin blood flow in the RA and SA groups was observed(0.105 9 of Spearman's rho, P=0.57).Conclusion: The data suggest that there is no association between De-qi sensation and local skin blood flow after acupuncture in healthy adults.The role of De-qi sensation for physiological changes and clinical outcomes should be further investigated in future acupuncture trials.     

USING ACUPUNCTURE TO RELIEVE PERIMENOPAUSAL SYNDROME:STUDY PROTOCOL OF A MULTICENTER RANDOMIZED CLINICAL TRIAL

Objective: In this article, we report the protocol of a randomized controlled trial of using acupuncture to treat perimenopausal syndrome, aiming to answer the question whether acupuncture is effective for relieving perimenopausal syndrome.Methods: A multicenter randomized controlled trial with two parallel arms is undergoing in China.Two hundred and six women with perimenopausal syndrome will be randomly assigned to a treatment group using acupuncture plus auricular acupressure(AA) and a control group using Climen? in a 1:1 ratio.Participants in the AA treatment group will receive acupuncture 3 times per week in the first 4 weeks and 2 times per week in the following 8 weeks, for a total 28 sessions over 12 weeks.Auricular points will be plastered by Semen Vaccariae 2 times per week for 12 weeks.The Climen? control group, a 28-day sequential hormone replacement therapy, is prescribing a tablet containing estradiol valerate(E2V) 2 mg per day for the first 11 d, and a tablet containing E2 V 2 mgplus cyproterone acetate(CPA) 1 mg per day for the following 10 d.The total treatment period of control group is three cycles.Post-treatment follow-up period will last 24 weeks.The primary outcome is Menopause Rating Scale(MRS) that assessed at baseline and 4, 8, 16, 24 and 36 weeks after randomization.The secondary outcomes are Menopause-Specific Quality of Life(MENQOL), average hot flash score during 24 h, and the serum estradiol(E2), follicle-stimulating hormone(FSH) and luteinizing hormone(LH) level.The first two secondary outcomes are measured at as the same point as MRS.And other second outcomes are measured at baseline and 12, and 24 weeks after randomization.Discussion: The result of this trial, which will be available in 2015, will clarify whether acupuncture is effective to relieve perimenopausal syndrome.     

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.     

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.     

GABA改变大脑皮层体感Ⅱ区机能状态对丘脑束旁核神经元电针效应的影响

<正> 关于大脑皮层参与疼痛及针刺镇痛过程的研究,近年来国内已有报导。我们也观察到电刺激大脑皮层体感Ⅱ区(SⅡ),可减弱丘脑中央中核(CM)神经元的伤害性反应,电针穴位同样获得CM神经元伤害性反应的抑制效应。我们设想大脑皮层参与疼痛及镇痛过程的机制可能是通过各种信息在皮层内的整合,也可能是通过某些信息影响皮层后产生了下行性作用。虽然,起源于皮层的下行冲动可影响皮层下许多神经元的活动,但对于伤害性传入信息的下行性影响较少研究,尤其是来自大脑皮层体感Ⅱ区