基于CONSORT声明和STRICTA清单的中英文针刺随机对照试验报告质量评价

目的：基于CONSORT声明和STRICTA清单评价中英文针刺随机对照试验（RCT）的报告质量。方法：计算机检索PubMed等7个数据库中中英文针刺RCT，检索时间为2015年1月1日至2019年12月31日，并采用CONSORT2010声明和STRICTA清单对纳入RCT进行报告质量评价。结果：共纳入中文文献506篇，英文文献76篇。在CONSORT声明的评估中，中文针刺RCT报告率<50%的条目占全部条目的 78.38%，试验背景和试验理由、试验设计、结局指标、样本量等25个条目的报告率均<10%；英文针刺RCT报告率<50%的条目占全部条目的 35.14%。报告率<10%的条目有5个。中英文文献在试验背景和试验理由、描述试验设计等15个条目的报告率差异超过50%。中英文文献的STRICTA清单各条目的报告率都相对较高，中文针刺RCT中，报告率<50%的条目占全部条目的 29.41%，为针刺治疗的理由、进针深度等；英文针刺RCT报告率<50%的仅有2个条目，分别为针刺治疗的理由及治疗场所和相关信息。中文针刺RCT在留针时间、治疗单元的频数和持续时...     

采用CONSORT和STRICTA评价针刺治疗单纯性肥胖症随机对照试验报告质量

目的 采用CONSORT声明和STRICTA标准评价国内针刺治疗单纯性肥胖症临床随机对照试验质量.方法 系统检索CNKI、CBM、VIP和万方4个数据库,手工检索所有中文针灸期刊、中医药核心期刊,纳入针刺治疗单纯性肥胖症的随机对照试验,并采用国际公认的CONSORT声明和报告针刺临床试验中干预措施的国际标准(STRICTA)进行报告质量评价.结果 共纳入112篇文献.根据CONSORT条目,在针刺治疗单纯性肥胖症的报告中,89篇(79.46%)描述了各组的基线情况和临床特征;33篇(29.46%)正确描述了产生随机分配序列的方法;1篇(0.89%)采用盲法,为单盲;尚没有文献提及分配隐藏、样本含量计算及意向治疗(ITT)分析法.根据STRICTA,7篇(6.25%)文献提及用针数目;67篇(59.82%)提及针具型号,24篇(21.43%)提及针刺深度;1篇(0.89%)报告了治疗师的资历.结论 目前针刺治疗单纯性肥胖症的研究报告质量普遍较低.今后应采用国际公认的CONSORT声明和STRICTA标准对针刺临床试验进行规范报告.     

采用CONSORT和STRICTA评价近5年针刺治疗偏头痛随机对照试验

目的采用试验报告统一标准(CONSORT)和针刺临床试验干预措施报告的标准(STRICTA)评价针刺治疗偏头痛随机对照试验(RCT)中英文文献的报告质量。 方法计算机检索PubMed、Cochrane Library、中国期刊全文数据库(CNKI)、维普期刊资源整合服务平台(VJIP)数据库,文种限制为中英文,检索时限为2012年1月至2017年4月。由2位评价者根据纳入与排除标准独立进行文献筛选,并采用国际公认的CONSORT声明和STRICTA标准评价报告质量。 结果最终纳入18篇文献,根据CONSORT条目,15篇(83.33%)描述各组的基线情况和临床特征;8篇(44.44%)提及产生随机分配序列的方法;10篇(55.56%)描述分配方案隐藏;10篇(55.56%)采用盲法;6篇(33.33%)提及样本含量的计算。根据STRICTA条目,8篇(44.44%)文献提及针刺反应;有11篇(61.11%)提及针刺深度;5篇文献(27.78%)报告治疗师的资历,亦提及医师的临床实践时间。 结论研究纳入的针刺治疗偏头痛中英文文献,根据CONSORT声明和STRICTA标准的条目,研究报告质量仍然存在不少问题。今后应提倡采用国际公认的CONSORT声明和STRICTA标准对针刺治疗的RCT进行规范报告。     

采用CONSORT和STRICTA评价针刺治疗糖尿病胃轻瘫随机对照试验报告质量

[目的]采用试验报告统一标准（CONSORT）和报告针刺临床试验中干预措施（STRICTA）标准评价针刺治疗糖尿病胃轻瘫随机对照试验的报告质量。[方法]计算机检索Cochrane图书馆临床对照试验数据库、PubMed、中国知识基础设施工程、维普等数据库。文种限制为中英文。纳入针刺治疗糖尿病胃轻瘫的随机对照试验,并采用CONSORT声明和STRICTA标准进行报告质量评价。[结果]共纳入针刺治疗糖尿病胃轻瘫随机对照研究28篇文献。根据CONSORT声明和STRICTA标准对纳入文献进行分析,无文献提及随机分配方案的隐藏、样本量的计算方法和治疗师资历。大部分研究对随机方法描述不清、盲法使用率低、未使用流程图、不良反应报道少、针刺细节报道不充分等问题。[结论]目前针刺治疗糖尿病胃轻瘫的研究报告质量普遍较低。今后应采用国际公认的CONSORT声明和STRICTA标准对针刺疗法进行规范报告。     

针刺治疗冠心病心绞痛随机对照试验的国内文献报告质量评价＊

目的 评价国内针刺治疗冠心病心绞痛随机对照试验的文献报告质量。方法 计算机检索中国知网，维普中文期刊全文数据库，万方数字化期刊群，中国生物医学文献数据库，收集国内针刺治疗冠心病心绞痛的随机对照试验（RCT），应用CONSORT 2010声明和STRICTA清单对纳入文献进行报告质量评价。结果 共纳入24篇文献。0篇文献完全符合CONSORT声明或STRICTA标准且各条目报告率参差不齐，其中受试者合格标准、针刺细节及结局指标等报告率较高，而试验设计、样本量估算、盲法、不良反应、试验注册及方案、针刺场所及治疗师背景等方面报告不足。结论 目前针刺治疗冠心病心绞痛随机对照试验的报告质量普遍较低。建议研究者加强临床试验方法学的系统学习并严格参照CONSORT声明和STRICTA清单进行临床研究报告，以期提高文献的报告质量。     

针刺治疗癌性疼痛随机对照试验的文献报告质量分析

采用国际公认的试验报告统一标准CONSORT声明和报告针刺临床试验中干预措施的国际标准STRICTA评价近10年国内外针刺治疗癌性疼痛的随机对照试验(RCT)的报告质量。计算机检索针刺治疗癌性疼痛的RCT,英文数据库为Pub Med、荷兰医学文献数据库(EMbase),中文数据库为中国期刊全文数据库(CNKI)、万方学术期刊全文数据库(Wanfang)、维普中文科技期刊数据库(VIP)、中国生物医学文献数据库(Sino Med),检索时限为2009年3月1日至2019年3月1日。最终纳入22篇中文文献和13篇英文文献。根据CONSORT声明条目,中文文献有1篇明确了主要、次要结局指标,8篇描述了随机化,均未描述分配隐藏、盲法,4篇描述了基线资料;英文文献有8篇明确了主要、次要结局指标,8篇描述了随机化,6篇描述了分配隐藏,7篇描述了盲法,13篇均描述了基线资料。根据STRICTA标准条目,中文文献有17篇描述了穴位名称,6篇描述了进针深度,17篇描述了针刺反应,均未描述治疗师资历;英文文献有12篇描述了穴位名称,7篇描述了进针深度,8篇描述了针刺反应,7篇描述了治疗师资历。中文文献对于针刺干预细节、针灸理论描述更加详尽,但对于随机化、盲法、数据分析等方法学部分则重视程度不够,而英文文献方法学部分质量更高,但对于中医针灸理论和针刺细节则相对弱化,需按照CONSORT声明和STRICTA标准进一步完善临床试验设计以提高临床证据的质量。     

基于CONSORT+STRICTA评价电针治疗神经根型颈椎病国内RCT的报告质量研究

目的:采用CONSORT和STRICTA标准评价电针治疗神经根型颈椎病RCT中文文献的报告质量。方法:计算机检索CNKI、CBM、VIP和万方数据库,查找所有有关电针治疗神经根型颈椎病的RCT。由两位评价者根据纳入和排除标准的进行筛选,并采用CONSORT声明的拓展版和STRICTA标准进行报告质量评价。结果:最终纳入RCT41篇。根据CONSORT条目,10(24.39%)篇提及产生分配序列的方法;3(7.31%)篇具体描述了分配方案隐藏方法;2(4.88%)篇采用单盲法;5(12.20%)篇提及随访与失访;仅1(2.44%)篇有样本量的估算;所有文献都没有试验注册。根据STRICTA评价,其中大部分文献对针刺种类、针刺数目、治疗场所相关信息和针灸师资历报道不充分,仅有5(12.20%)篇完整报道了针刺细节。结论:目前电针治疗神经根型颈椎病的RCT质量偏低。今后临床试验应严格执行CONSORT声明和STRICTA标准对电针治疗神经根型颈椎病进行规范报告。     

国内外针刺治疗慢性颈痛随机对照试验的文献质量分析

采用国际公认的试验报告统一标准CONSORT (Consolidated Standards for Reporting of Trials,CONSORT)声明和报告针刺临床试验中干预措施的国际标准STRICTA(Standards for Reporting Interventions in Controlled Trials of Acupuncture,STRICTA)评价近10年国内外针刺治疗慢性颈痛的随机对照试验(randomized controlled trial,RCT)的报告质量。计算机检索针刺治疗慢性颈痛的RCT,英文文献通过PubMed和EMbase,中文文献通过中国知网、万方数据知识服务平台、维普中文期刊服务平台、中国生物医学文献数据库,检索时限为2008年1月至2018年1月。最终纳入29篇中文文献和10篇英文文献。根据CONSORT条目,中文文献有28篇(96.6%)描述了基线资料,23篇(79.3%)描述了随机说明,0篇描述了分配隐藏,3篇(10.3%)提及盲法;英文文献有6篇(60.0%)描述了基线资料,8篇(80.0%)描述了随机说明,8篇(80.0%)描述了分配隐藏,7篇(70.0%)描述了盲法。根据STRICTA条目,中文文献有8篇(27.6%)描述了针具类型,18篇(62.1%)描述了针刺深度,24篇(82.8%)描述了针刺反应,0篇描述了治疗师资历;英文文献有5篇(50.0%)描述了针具类型,8篇(80.0%)描述了针刺深度,3篇(30.0%)描述了针刺反应,4篇(40.0%)描述了治疗师资历。中文文献在针刺细节的报告方面优于英文文献,英文文献在试验设计的报告方面略优于中文文献,而两者均有很多不足,需按照CONSORT声明和STRICTA标准进一步完善临床试验设计以提高临床证据的报告质量。     

针灸治疗功能性便秘随机对照试验文献报告质量评价

目的评价针灸治疗功能性便秘随机对照试验文献报告质量。方法通过检索CENTRAL、Medline、Embase、AMED、CNKI、VIP、WF 7个数据库,筛选针灸治疗功能性便秘的随机对照试验,文献语种限定为中文或英文。采用CONSORT声明(2010)和STRICTA标准(2010)进行文献报告质量评价。结果研究共纳入12篇RCT,大部分文献存在文题(25.00%)、样本量估算(16.67%)、盲法实施(33.33%)、意向性分析(8.33%)、受试者流程(8.33%)、对照组合理选择(41.67%)、结局和估计值、试验注册、针灸治疗师背景等问题。结论基于CONSORT声明与STRICTA标准对针灸治疗功能性便秘的临床随机对照试验报告质量评价结果表明当前文献报告质量普遍偏低,在今后的针灸临床试验设计时应参照CONSORT声明与STRICTA标准,提高针灸临床试验报告质量。     

基于CONSORT声明和STRICTA评价针灸治疗腰椎间盘突出症随机对照试验报告质量

目的:使用CONSORT 2010和STRICTA标准对国内针灸治疗腰椎间盘突出症随机对照试验(RCT)报告质量进行评价。方法:系统检索国内文献数据库,包括中国知网(CNKI)、万方数据库(WF)、中国生物医学文献数据库(CBM)、维普中文期刊全文数据库(VIP),语种限制为中文,筛选符合条件的针灸治疗腰椎间盘突出症的RCT,利用CONSORT 2010和STRICTA进行报告质量评价。结果:共纳入178篇文献。根据CONSORT 2010条目,纳入文献中多数针灸治疗腰椎间盘突出症文献未按要求对样本量、分配隐藏、盲法及统计学方法进行规范报告,且所有文献均未进行临床注册;根据STRICTA条目,少数文献对治疗场所及治疗师背景做出报告,且尚未有文献进行个体化治疗报告。结论:目前针灸治疗腰椎间盘突出症随机对照试验文献报告质量普遍偏低,今后应采用CONSORT 2010声明和STRICTA标准对针灸治疗的RCT进行规范报告。     

Reporting quality and effect size comparison in randomized controlled trials of bo's abdominal acupuncture using CONSORT statement and STRICTA

OBJECTIVE: To evaluate the reporting quality of randomized controlled trials(RCT) that compared Bo's abdominal acupuncture with conventional body acupuncture, and compare the efficacy and safetybetweenthembyperforminga Meta-analysis.METHODS: All RCTs comparing Bo's abdominalacupuncture with conventional body acupuncture were included. English and Chinese databases were searched from their respective inceptions to March 2014. The reporting quality was assessed according to the "Consolidated Standards of Reporting Trials"(CONSORT) checklist for parallel RCTs and the revised "Standards for Reporting Interventions in Clinical Trials of Acupuncture"(STRICTA). A Meta-analysis was conducted to synthesize the effect sizes,and publication bias was evaluated by the Egger linear regression test using Stata.RESULTS: Ninety-seven studies were included, of which most lacked adequate reporting information, and 80.4% showed that the efficacy of abdominal acupuncture is superior to conventional body acupuncture, especially for the following diseases:lumbar disc herniation, cervical spondylosis, omarthritis and cervical vertigo, except simple obesity.Effect-sizes were controversial when evaluating different outcomes.CONCLUSION: The international standard CONSORT statement and STRICTA guidelines should be strictly applied when reporting acupuncture RCTs in the future. Abdominal acupuncture appears to be more effective compared with conventional body acupuncture for some diseases. However, further high quality blind RCTs using validated outcomeindexesandstandardreportingarewarranted.     

Quality of randomized controlled trials in acupuncture treatment of hepatitis B virus infection--a systematic review

The purpose of this work was to evaluate the quality of randomized controlled trials (RCTs) with acupuncture treatment for hepatitis B virus (HBV) infection. A systematic review of the literature for clinical trials was performed up to September 2008. RCTs assessing acupuncture point stimulation for patients with HBV infection were considered for inclusion. The search identified 70 relevant trials meeting the inclusion. The quality of each trial was assessed using the revised Consolidated Standards for Reporting of Trials (CONSORT) statement, facilitating critical appraisal and interpretation of RCTs by providing guidance to authors; the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) recommendations, acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies; and the Jadad scale, widely used in different settings to assess methodological quality. All trials were reported "randomization", but only 2 mentioned the methods. None reported allocation concealment, a method used to keep clinicians and participants unaware of upcoming assignments. None reported blinding. 3 studies described the number of withdrawals/dropouts, while none used the analysis of "intention to treat". The reported items of the STRICTA recommendations were assigned for 65% (13 out of 20). Only 2 studies had a high quality Jadad score. The results from our work show that the quality was low caused by their methodological flaws and inadequate reports. Further rigorous clinical trials for HBV infection would be necessary to evaluate the efficacy of acupuncture.     

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.     

Qualitätsstandards randomisierter kontrollierter Akupunkturstudien

To allow scientific evaluation of clinical acupuncture trials, certain internationally approved quality standards should be taken into account. The guidelines of Good Clinical Practice GCP should be the basis of every clinical trial. Consideration of the Consolidated Standards of Reporting Trials (CONSORT) are required for publication by most of the journals. GCP and CONSORT include the most important quality standards for clinical studies. In addition, specific quality standards need to be considered in clinical acupuncture trials as reported in the Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA).     

针灸治疗慢性盆腔炎随机对照试验质量报告

目的:采用CONSORT声明和STRICTA标准评价国内针灸治疗慢性盆腔炎临床随机对照试验质量。方法:利用计算机检索与手工检索。检索CNKI、CBM、VIP和万方4个数据库,结合手工检索相关期刊,筛选出符合研究标准的文献,采用CONSORT声明和STRICTA标准进行质量评价。结果:共纳入合格文献85篇。大部分文献存在随机方法描述不清和无随机隐藏、盲法使用率低、无样本量计算、无意向治疗分析、针刺细节报道不充分、无针刺治疗医生的资历等问题。结论:针灸治疗慢性盆腔炎的临床随机对照试验质量普遍较低,影响报道的可靠性和同质可比性。为提高针灸临床随机试验可靠性和质量,应该将CONSORT声明和STRICTA标准引入针灸临床随机试验设计并严格执行。     

Effectiveness of acupuncture in postoperative ileus: a systematic review and Meta-analysis

OBJECTIVE: To conduct a systematic review and Meta-analysis of the effectiveness of acupuncture and common acupoint selection for postoperative ileus(POI).METHODS: Randomized controlled trials(RCTs)comparing acupuncture and non-acupuncture treatment were identified from the databases Pub Med, Cochrane, EBSCO(Academic Source Premier and MEDLINE), Ovid(including EvidenceBased Medicine Reviews), China National Knowledge Infrastructure, and Wanfang Data. The data from eligible studies were extracted and a Meta-analysis performed using a fixed-effects model.Results were expressed as relative risk(RR) for dichotomous data, and 95% CI(confidence intervals)were calculated. Each trial was evaluated using the CONSORT(Consolidated Standards of Reporting Trials) and STRICTA(STandards for Reporting Interventions in Controlled Trials of Acupuncture) guide-lines. The quality of the study was assessed using the Grading of Recommendations, Assessment, Development and Evaluation(GRADE) approach.RESULTS: Of the 69 studies screened, eight RCTs were included for review. Among these, four RCTs(with a total of 123 patients in the intervention groups and 124 patients in the control groups) met the criteria for Meta-analysis. The Meta-analysis results indicated that acupuncture combined with usual care showed a significantly higher total effective rate than the control condition(usual care)(RR1.09, 95% CI 1.01, 1.18; P = 0.02). Zusanli(ST 36) and Shangjuxu(ST 37) were the most common acupoints selected. However, the quality of the studies was generally low, as they did not emphasize the use of blinding.CONCLUSION: The results suggested that acupuncture might be effective in improving POI; however,a definite conclusion could not be drawn because of the low quality of trials. Further large-scale,high-quality randomized clinical trials are needed to validate these findings and to develop a standardized method of treatment. We hope that the present results will lead to improved research, resulting in better patient care worldwide.