Current situation on the reporting quality of randomized controlled trials in 5 leading Chinese medical journals

Objective： The Consolidated Standards for Reporting of Trials （CONSORT） statement has already proved to be an efficient standard for reporting quality of randomized controlled trials （RCTs）. However, most of the Chinese medical journals have not endorsed the CONSORT statement. The current situation about the reporting quality of RCTs in Chinese medical journals is still unclear. The purpose of the study was to evaluate the reporting quality of RCTs on papers published in 5 leading Chinese medical journals. Methods： We evaluated 232 original RCT papers using a reporting quality scale based on CONSORT statement from 2001 to 2006 in 5 Chinese medical journals （Journal type 1） without adoption of CONSORT and Chinese Journal of Evidence-based Medicine （Journal type 2） which adopted CONSORT in 2004. We measured the inclusion of 26 items for the reporting quality scale and 6 core items of each RCT report, gave score to each item and calculated the total score obtained in each report and the proportion of reports including individual items. The reporting quality of RCT trials from 2001 to 2003 （pre-adoption period） was compared with that from 2004 to 2006 （post-adoption period）. Results： The average reporting quality of RCTs was moderate （mean score, 15.18）, and the mean score of the 6 core items was low （mean score, 1.09） in 5 leading journals. The difference in the total score and the score of the 6 core items between pre-adoption period （2001-2003） and post-adoption period （2004-2006） was statistically significant （P=0.003; P=0.000）. Interaction between journal type and period was not significant （F=0.76; P=0.383）. We concluded that the change tendency of reporting quality between Journal type 1 and 2 was not different. But as to the core items of sequence concealment and intention-to-treat analysis, the increases were greater for Journal type 2 when evaluated against Journal type 1 （P=0.038; P=0.016）. Conclusion： The reporting quality of RCT trials in 5 leading Chinese medical journals is improving. However, the lack of important items in RCT trials remains a serious problem. We recommend the endorsement of the Consolidated Standards for Reporting of Trials statement in Chinese medical journals and the continuing education on evidence-based medicine in China.     

Survey and practice of reporting quality of randomized controlled clinical trials on traditional Chinese medicine

Evidence obtained from randomized controlled trials （RCTs） has been generally accepted as the gold standard in the evaluation of clinical effectiveness. Readers need to understand the trial design, implementation, results, analysis and interpretation, so as to fully Jnderstand the results of RCTs. Thus, the investigators of RCTs have to report these items in a complete, accurate and clear manner. Since 1998, we have conducted several evaluations on the reporting quality of RCTs published in Chinese journals on traditional Chinese medicine （TCM） and results have shown that there is an urgent need for higher quality RCTs on TCM.     

Development and Influencing Factors of Compliance Behaviors of Investigators in Clinical Trials

The development and influencing factors of compliance behavior of investigators in clinical trials were explored. According to literature review, a hypothetical model of development of compliance behavior of investigators in clinical trials was established, and the influencing factors of compliance behavior of investigators and their interrelationships were studied based on questionnaire survey of five hundred investigators sampled randomly from one hundred clinical trial institutions in China. Cron- bach＇s alpha coefficient and structural equation modeling were adopted to empirically analyze the re- suits. Six variables in the hypothetical model were included： compliance behavior of investigators, credibility of clinical trial, capability of government regulation, quality control of sponsor, quality con- trol of clinical institution and compliance intention of investigators. Empirical analysis showed that the compliance behavior of investigators in clinical trial was directly affected by compliance intention of investigators, quality control of sponsor and quality control of clinical institution. In addition, credibility of clinical trial and capability of government regulation indirectly affected the compliance behavior of investigators in clinical trial through influencing the compliance intention of investigators, quality con- trol of sponsor and quality control of clinical institution. Quality control of sponsor was affected by credibility of clinical trial and capability of government regulation while quality control of clinical in- stitutinn wan only influenced by capability of government regulation.     

Impact Evaluation of CONSORT and STRICTA Guidelines on Reporting Quality for Randomized Controlled Trials of Acupuncture Conducted in China

Objective:To evaluate and compare the reports' qualities of acupuncture randomized controlled trials(RCTs) conducted in China before and after the implementation of two guidelines,i.e.,the Consolidated Standards of Reporting Trials(CONSORT) statement and the Standards for Reporting Interventions in Controlled Trials of Acupuncture(STRICTA).Methods:Proportions of studies that reported CONSORT and STRICTA items were compared for the years before and after implementation of these two guidelines.In addition,the total score of each item's reporting were calculated and reported differences during different date ranges were compared.Results:For CONSORT items(maximum score 8),there was evidence of a slight improvement in reporting between 1994-1995 and 1999-2000 combined(2.5 + 0.6) and 2004-2005 and2009-2010 combined(3.0 ±0.9;difference 0.4,95%confidence interval,0.3 to 0.6,P0.01).For STRICTA items(maximum score 17),there was evidence that a slight improvement in reporting between 1994-1995 and 1999-2000 combined(8.6±2.1) and 2004-2005 and 2009-2010 combined(10.1 ±1.8;difference1.5,95%confidence interval,1.1 to 1.9,P0.01).Conclusion:Quality of reporting for RCTs of acupuncture treatment conducted in China have generally improved since the introduction of the STRICTA and CONSORT guidelines.     

Review of the Regulations for Clinical Research in Herbal Medicines in USA

In 2012,USA Food and Drug Administration（FDA） approved 39 new drugs,however,there are only two botanical drugs（one topical and one oral）approved by FDA since the publication of the FDA＇s industry guidelines for the botanical drug product in June 2004.The approval shows the Western guideline can be used for herbal medicines,authors investigate current regulation on herbal medicine clinical research,identify challenges conducting clinical trials,and seek to produce some guidance for potential investigators and sponsors considering a clinical trial in this area.Key words were formulated for searching on Medline and FDA website to locate relevant regulations for clinical research in herbal medicines to understand current environment for herbal medicine usage and examine the barriers affecting herbal medicine in clinical trials.Authors critically explore case study of the 1st FDA approved botanical drugs,Veregen（sinecatechins）,green tea leaves extract,a topical cream for perianal and genital condyloma.In consideration of current regulation environment in USA,based on the findings and analysis through the literature review and Veregen case study,authors produce and propose a Checklist for New Drug Application of Herbal Medicines for potential investigators and sponsors considerina in a herbal medicine clinical trial.     

Assessing blinding in randomised controlled trials of acupuncture: Challenges and recommendations

The revision of CONSORT guidelines for reporting blinding in randomised controlled trials is the subject of controversy and criticism.To determine whether the criticism is justified,in this short communication paper we discuss the problems encountered in the methodology of the assessment of blinding,and the reporting of blinding in randomised controlled trials and the standards of reporting on blinding with reference to their usage in clinical trials of acupuncture for chronic pain.To conclude we recommend two simple guidelines:the development of sound clinical protocols that anticipate potential difficulties and reinforce overall internal validity,and secondly. the accurate reporting of the methodologies used to ensure a clear view of blinding procedures.     

Integrated traditional and Western medicine for treatment of depression based on syndrome differentiation:a meta-analysis of randomized controlled trials based on the Hamilton depression scale

OBJECTIVE:To systematically review the benefits of integrated traditional and Western medicine therapies based on the Hamilton depression scale(HAMD) following syndrome differentiation of depression.METHODS:We searched six English and Chinese electronic databases for randomized clinical trials(RCTs) on integrated traditional and Western medicine for treatment of depression.Two authors extracted data and independently assessed the trial quality.RevMan 5 software was used for data analyses with an effect estimate presented as weighted mean difference(WMD) with a 95% confidence interval(CI).RESULTS:Seven RCTs with 576 participants were identified for this review.All trials were eligible for the meta-analysis and were evaluated as unclear or having a risk of bias.Meta-analysis showed,compared with Western medicine alone,integrated traditional and Western medicine based on syndrome differentiation could improve the effect of treatment represented by the HAMD [WMD=-2.39,CI(-2.96,-1.83),Z=8.29,P<0.00001].There were no reported serious adverse effects that were related to integrated traditional and Western medicine based therapies in these trials.CONCLUSIONS:Integrated traditional and Western medicine based therapies for the syndrome differentiation of depression significantly improved the HAMD,illustrating that combining therapies from integrated traditional and Western medicine for treatment of depression is better than Western medicine alone.However,further large,rigorously designed trials are warranted due to the insufficient methodological rigor seen in the trials included in this study.     

穴位埋线治疗过敏性鼻炎：一项系统综述

Objective： To assess the effectiveness and the possible adverse effects of catgut implantation at acupoints for allergic rhinitis （AR）. Methods： This systematic review was carried out in accordance with the Cochrane Handbook version 5.1.0 and the Preferred Reporting Items for Systematic Reviews and Meta- Analyses statement. Extensive literature searches were conducted in PubMed, Excerpta Medical Databases, the Cochrane Library, the China National Infrastructure, Wanfang Chinese Digital Periodical and Conference Database, and the Weipu Chinese Science and Technique Journals Database. The Chinese Clinical Trial Registry Center was also searched for ongoing trials up to September 2012. Randomized controlled trials （RCTs） or quasi-RCTs were included. Risk of bias assessment was performed using the Cochrane tool for assessing risk of bias. Results： Five RCTs with 285 participants were found from 49 relevant studies, but there was just one RCT which met the inclusion criteria for this review. The study showed that treatment of catgut implantation at acupoints could lead to a better alleviation of the signs and symptoms of AR than the crude herb moxibustion. No adverse events were reported in this study. Conclusions： Because of the methodological shortcoming and the risk of bias of the included trial catgut implantation was proved with only limited evidence for the treatment of AR. Robust RCTs with high quality and larger sample size in this field are hoped to be carried out in the future.     

Qingkailing Injection (清开灵注射液) for Treatment of Children Pneumonia Induced by Respiratory Syncytial Virus: A Meta-Analysis of Randomized Controlled Trials

Objective: To evaluate the efficacy and safety of Qingkailing Injection(清开灵注射液, QKL) for treatment of children pneumonia caused by respiratory syncytial virus(RSV). Methods: Randomized clinical trials(RCTs) comparing QKL with ribavirin injection in the treatment of children pneumonia induced by RSV were searched in Pub Med, Science Direct, Cochrane Library, Chinese VIP database, CNKI and Wanfang databases from their inception to March 2014. Meta-analyses were performed using RevMan 5.2 software. The methodological quality of the selected RCTs was evaluated by the Modified Jadad Score. The primary outcome measures were effective rate and the secondary outcomes were relief time of fever and cough. Results: Seven RCTs with 992 cases published from 2008 to 2013 were identified. The meta-analysis results indicated that QKL was more effective in cure rate [risk ratios(RR)=1.32, 95% CI(1.17, 1.50), P0.01], total effective rate [RR=1.07, 95% CI(1.02, 1.13), P=0.009] and less fever clearance time [mean difference=–0.73, 95% CI(–1.22, –0.23), P=0.004], compared with ribavirin injection in the treatment of RSV-induced children pneumonia. No dead case was reported in all trials. There were 3 trials mentioned adverse events, 2 reported no obvious adverse event occurred while 1 reported adverse events described as skin hypersensitivity, elevation of ALT, a mild abnormal of hepatic and renal function in both QKL and ribavirin group. Conclusions: QKL was an effective and relatively safe option for the treatment of RSV-induced children pneumonia. These therapeutic effects were promising but need to be interpreted with caution due to variations in the treatment and methodological weakness in the studies.     

基于中医三型辨证治疗2型糖尿病的系统综述

Objective： To evaluate the efficacy and safety of ＂Three-Typed Syndrome Differentiation＂ （I-TSD） in treating type 2 diabetes mellitus patients. Methods： A systematic review and meta-analysis was done based on the clinical diabetes treatment literature of the ＂I-I＇SD＂. Overseas databases like the PubMed/MEDLINE, EMBASE, Cochrane Library and Cochrane Central Register of Controlled Clinical Trials, and China databases like China Biology Medicine Disc （CBM）, Chinese national Knowledge Infrastructure （CNKI）, Wanfang database, and VIP database, without limitation on language, were included with the time limitation from Jan 1982 to Dec 2012 by retrieval of relative original clinical research articles. Results： Nineteen articles where contains 1,840 diabetes patients were obtained, in which no adverse reactions were reported. Of these, 14 literatures involved the effect of fasting blood glucose （FBG）, 10 involved that of postprandial 2-h blood glucose （P2hBG）, and 19 involved the overall efficacy based on the national Chinese medicine （CM） diagnosis and treatment standard of diabetes. All the meta-analysis results prefer to the ＂TTSD＂ groups （CM＋Westem medicine Based on I-I＇SD）. The results show that, beside the efficacy of Westem medicine, the concentrations of FBG and P2hBG in ＂TTSD＂ groups continue to drop with statistical significance. For ＂TTSD＂ groups, the FBG subsequently dropped 1.03 mmol/L, 95%CI [1.24,0.82] （P〈0.00001）, the P2hBG subsequently dropped 1.09 mmol/L, 95% CI [1.61, 0.57] （P〈0.0001）, and the overall efficacies benefit 3.46 times those of Western medicine alone, 95% CI [2.67,4.48] （P〈0.00001）. Conclusions： The CM by the diagnosis and treatment of type 2 diabetes based on ＂TTSD might be safe and effective, and could better improve both blood glucose and the overall status of patients, including symptoms.     

Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation

CONTEXT: The Consolidated Standards for Reporting of Trials (CONSORT) statement was developed to help improve the quality of reports of randomized controlled trials (RCTs). To date, a paucity of data exists regarding whether it has achieved this goal. OBJECTIVE: To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs. DESIGN AND SETTING: Comparative before-and-after evaluation in which reports of RCTs published in 1994 (pre-CONSORT) were compared with RCT reports from the same journals published in 1998 (post-CONSORT). We included 211 reports from BMJ, JAMA, and The Lancet (journals that adopted CONSORT) as well as The New England Journal of Medicine (a journal that did not adopt CONSORT and was used as a comparator). MAIN OUTCOME MEASURES: Number of CONSORT items included in a report, frequency of unclear reporting of allocation concealment, and overall trial quality score based on the Jadad scale, a 5-point quality assessment instrument. RESULTS: Compared with 1994, the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998, and this increase was statistically significant for the 3 adopter journals (pre-CONSORT, 23.4; mean change, 3.7; 95% confidence interval [CI], 2.1-5.3). The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals, and this change was statistically significant for adopters (pre-CONSORT, 61%; mean change, -22%; 95% CI, -38% to -6%). Similarly, 3 of the 4 journals showed an improvement in the quality score for reports of RCTs, and this increase was statistically significant for adopter journals overall (pre-CONSORT, 2.7; mean change, 0.4; 95% CI, 0.1-0.8). CONCLUSION: Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs.     

Chuna Therapy for Musculoskeletal Pain: A Systematic Review of Randomized Clinical Trials in Korean Literature

Objective

To evaluate the effectiveness of Chuna for the treatment of musculoskeletal pain as reported in Korean literature.

Methods

We conducted an electronic literature search using seven Korean databases and manually searched six traditional Korean medicine journals. Risk of bias was assessed with the Cochrane criteria.

Results

Six randomized controlled trials (RCTs) were included in the study. Compared with standard care, three RCTs suggested favorable effects of Chuna on neck pain due to a hypolordotic cervical spine, low back pain caused by traffic accidents, and low back pain. In contrast, compared with standard care, three RCTs failed to show positive effects on temporomandibular joint disorder, mandibular movement, and neck pain caused by traffic accidents.

Conclusions

Currently, the evidence of the effectiveness of Chuna for the treatment of musculoskeletal pain is not convincing. Further rigorously designed trials are warranted to determine its effectiveness.     

头针治疗帕金森病：一项随机对照试验的系统评价

Objective: To evaluate the effectiveness of scalp acupuncture (SA), a modern acupuncture technique specialized to neurological disorders, in managing motor function and symptoms for Parkinson''s disease (PD) patients. Methods: Two independent reviewers extracted data from all of the randomized clinical trials (RCTs) that assessed the efficacy of SA for PD compared with conventional therapies (CTs). Sixteen electronic databases were searched. The risk of bias was appraised with the Cochrane Collaboration tool, and the reporting of the included studies was evaluated by the Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist and the revised Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) guidelines. Results: In total, 4 RCTs met the inclusion criteria. As assessed by the Unified PD Rating Scale (UPDRS), 2 RCTs showed that SA combined with CTs proved superior to CTs alone [60 cases; weighted mean difference, –3.94; 95% confidence interval (CI), –6.05 to –1.84, P=0.01; I2=0%]. Based on the Webster scale, however, 3 RCTs showed no superior effect of SA when combined with CTs with high heterogeneity (154 cases; risk ratio, 1.29; 95% CI, 0.79 to 2.12, P=0.30; I2=84%). The Cochrane risk of bias, adherence to the CONSORT and the STRICTA checklist showed that the quality of all the included RCTs was generally low. Conclusions: The result of our systematic review and meta-analysis suggested that the effectiveness of SA for PD is promising, however, the evidence is not convincing. A sham-controlled RCT design that adheres to the CONSORT and STRICTA guidelines to overcome methodological weakness and that includes a large sample size is strongly recommended to confirm the precise effect of SA on PD.     

CONSORT 2010说明与详述：报告平行对照随机临床试验指南的更新

大量证据显示随机对照临床试验（randomised controlled trial,RCT）的报告质量不理想。报告不透明,则读者既不能评判试验结果是否真实可靠,也不能从中提取可用于系统综述的信息。最近的方法学分析表明,报告不充分和设计不合理与对治疗效果产生评价偏倚有关。这种系统误差对RCT损害严重,而RCT正是以其能减少或避免偏倚而被视为评价干预措施的金标准。为了提高RCT的报告质量,一个由专家和编辑组成的工作组制定了临床试验报告的统一标准（Consolidated Standards of Reporting Trials,CONSORT）声明。CONSORT声明于1996年首次发表,并于2001年更新。声明由对照检查清单和流程图组成,供作者在报告RCT时使用。许多核心医学期刊和主要国际性编辑组织都已认可CONSORT声明。该声明促进了对RCT的严格评价和解释。2001年,在对CONSORT进行修订时,人们就已经清楚地认识到,解释和说明制定CONSORT声明的原理,有助于研究人员等撰写或评价临床试验报告。一篇CONSORT说明与详述文章于2001年同2001版CONSORT声明一起发表。2007年1月的专家会议之后,对CONSORT声明作了进一步修订并已发表,即＂CONSORT2010声明＂。这次更新对原版对照检查清单作了文字上的修改,使其更为明晰,并收入了与一些新近才认识到的主题相关的建议,如选择性报告结局产生的偏倚。说明与详述文件旨在加强人们对CONSORT声明的理解、应用和传播,这次也作了大量修订,对每一项新增或更新的清单条目的含义和增改理由进行了解释,提供了优秀的报告实例,还尽可能地提供了相关的经验性研究的参考文献。文中收入了若干流程图实例。＂CONSORT2010声明＂、其说明与详述文件,以及相关网站（www.consort-statement.org）,对于改进随机临床试验报告必将有所裨益。     

Expert Consensus on Laparoscopic Hepatectomy （2013 Version）

Background： Laparoscopic hepatectomy has many advantages over open surgery, including minimiza- tion of local injury, reduced systemic reactions, and faster postoperative recovery. The aim of this ＂Consensus＂ is to provide guidance and reference to surgeons who perform, or are interested in per- forming laparoscopic liver surgeries. Methods： The National Hepatic Surgery Group of the Society of Surgery, a professional society of the Chinese Medical Association, gathered 60 expert hepatic surgeons in Wuhan, China in December 2012, and an ＂Expert Consensus on Laparoseopic Hepatectomy＂ was developed. Results： The types of hepatectomy, indications and contraindications, preoperative preparation, anes- thesia, patient position, insuffiation pressure, port position, control of hepatic inflow and outflow, indi- cations for conversion to open surgery, and surgical devices and equipment are reviewed. Techniques and procedures of various laparoscopic hepatectomies are also discussed.     

Survey of "instructions to authors" of Indian medical journals for reporting of ethics and authorship criteria

This study looked at information on ethics reporting and authorship in the "instructions to authors" section of Indian medical journals. Instructions to authors in 59 Indian medical journals were examined for guidance on ethics reporting and authorship. Guidance regarding ethics was mentioned in 43 (72.8%) journals; assent from minors was mentioned in 9 (15.2%) journals; approval from an animal ethics committee was mentioned in 10 (16.9%) journals; authorship criteria were mentioned in 38 (64.5%) journals. Authorship criteria according to the International Committee of Medical Journal Editors were mentioned in 35 (59.3%) journals. Guidance regarding contributors' details was mentioned in 30 (50.8%) journals. These findings suggest that many editors of Indian medical journals must upgrade their instructions to authors to include ethical requirements.