Objective To assess the quality of reporting of randomized controlled trials(RCTs) on traditional Chinese medicine(TCM) in China from 1999 to 2004 by CONSORT statement and Jadad scale. Methods We randomly selected 13 journals of TCM including Chinese Journal of Integrated Chinese and Western Medicine,ect using stratified sampling from about 100 journals of TCM in mainland China, and all issues of selected journals published from 1999 to 2004 were hand-searched according to the hand-search guideline developed by Cochrane Collaboration. All reviewers were trained in the method of evaluating RCTs . A comprehensive quality assessment of each RCT was completed using methods including the revised consolidated standards of reporting trials (CONSORT) checklist and Jadad scale. Disagreements were resolved by consensus. Results A total of 7422 RCTs were identified, and the percentage of RCTs was significantly increased by 18.6%, 23.9%, 27.5%, 28.8%, 33.0% and 35.6% from 1999 to 2004. The mean Jadad score was 1.03 ± 0.61 in all trials with 1 RCT with 5 points, 14 with 4 points, and 102 with 3 points, from 1999 to 2004, the mean Jadad score was 0.85±0.53 (n=746), 0.82±0.63 (n=941), 0.90±0.61 (n=1 243), 1.03±0.60 (n=1 325), 1.12±0.58 (n=1 533) and 1.20±0.62 (n=1 634) respectively, which was improved continuously but slowly. 39.4% of the items in CONSORT, which was equivalent to 11.82 (standard deviation=5.78) of a total of 30 items, were reported across those trials. Some important methodological components of RCTs such as sample size calculation (1.1%), randomization sequence (7.9%), allocation concealment (0.3%), implementation of the random allocation sequence (0.0%) , analysis of intention to treat (0.0%), were incompletely reported. Conclusion Our study suggests that the quality of reporting has been improved but still in poor status, which would urgently promote the establishment of the CONSORT for TCM.
Objective To assess the reporting quality of noninferiority and equivalence randomized controlled trials (RCTs) related to Traditional Chinese Medicine (TCM). Methods The noninferiority and equivalence RCTs related to TCM were searched, and the quality of the included RCTs was identified in accordance with the extended version of CONSORT statement which refers to the reporting standard of noninferiority and equivalence RCTs. Results A total of 13 noninferiority and equivalence RCTs were included. Except for the common questions of RCTs in reporting quality, some contents related to noninferiority and equivalence trials in reporting were not enough: a) The title of RCTs did not reflect the most important content of the literature; b) The introduction of background was quite simple. The rationale about noninferiority and equivalence trials, and the effectiveness of positive control were not clearly defined; c) All literatures did not indicate whether the subjects, interventions and outcomes in the noninferiority and equivalence trials were identical or similar to those in previous trials of defining the effectiveness of control treatment; d) Most literatures did not define the critical value of noninferiority and equivalence, and did not estimate the sample size; e) Only half of literature described the statistical methods of noninferiority test and equivalence test; and f) Some literature had mistakes in noninferiority and equivalence conclusion. Conclusion The researchers still need deeper understanding of the theoretical basis of noninferiority and equivalence trials. The reference to the extended version of CONSORT statement, which refers to the reporting standard of noninferiority and equivalence RCTs, is helpful for researchers to identify the key points of the design, performance and reporting of the noninferiority and equivalence RCTs, to lay stress on the related contents of noninferiority and equivalence trial reporting, and to radically improve the reporting quality of such clinical trials.
Objective To investigate the current situation of randomized controlled trials (RCTs) on the treatment of Sjogren’s syndrome with Traditional Chinese Medicine (TCM), and to assess whether there is adequate evidence for clinical practice. Methods Such databases as CNKI, VIP, CBM and PubMed were searched from their establishment date to June 2010 to collect the RCTs on the treatment of Sjogren’s syndrome with TCM according to the predefined inclusion criteria. And the quality was assessed by using the Jadad scale, the revised CONSORT statement and other self-defined indexes.Results Among 19 included RCTs, 1 literature scored four points, 4 scored two points, 13 scored one point, and 1 scored zero point according to Jadad scale; no RCT performed the allocation concealment. According to the CONSORT criteria, 19 RCTs accounting for 100% reported the diagnostic criteria, implement of interventions and result, 11 RCTs applied the 2002 international diagnosis and classification criteria of Sjogren’s syndrome, 17 RCTs carried out positive control including one based on the standard treatment, and two RCTs applied only blank control without placebo control. All RCTs took the comprehensive efficacy assessment as the outcome index, but only 6 RCTs (31.6%) assessed both clinical efficacy and TCM syndrome efficacy. Among 6 RCTs (31.6%) describing the random sequence, no RCT reported the detailed methods. Except 1 RCT (5.3%) carried out the double blinding, all the others were non-blind trials. And only 1 RCT adopted analog. Conclusion Currently, the methodology and reporting quality of studies on the treatment of Sjogren’s syndrome with TCM are not good enough to provide reliable evidence for clinical practice.
Objective To assess the quality of the published randomized controlled trials published in Journal of Beijing University of Traditional Chinese Medicine (JBUTCM), Acta Universitatis Traditionis Medicalis Sinensis Pharmacologiaeque Shanghai (AUTMSPS), Journal of Guangdong University of Traditional Chinese Medicine (JGUTCM), and Journal of Chengdu University of Traditional Chinese Medicine (JCUTCM) from 2000 to 2005. Method Guided by the Cochrane Center hand-searching guidelines, we searched 24 volumes (111 issues) of the four journals. The data were extracted according to the principles of clinical epidemiology and consolidated standards of reporting trials (CONSORT), as well as an evaluation scale for randomized controlled trials (RCTs). The data were managed by descriptive analysis and uniformity test. Results There were 365 RCTs. The diagnostic criteria were reported in 297 trials (81.37%). The inclusion and exclusion criteria were reported in 143 trials (39.18%) and 132 trials (36.16%), perspectively, None mentioned the estimation of sample size. The randomization and allocation concealment were reported in 70 trials (19.18%) and 9 trials, perspectively. The baseline data were described in 292 trials (80.00%). Blinding was mentioned in 35 trials (9.59%).Withdrawal occurred in 20 trials (5.48%). Informed consent was acquired in 2 trials. Adverse drug reactions were described in 97 trails (26.58%). Conclusion There are deficiencies in the reporting of these RCTs, Most of the trials do not describe the randomization, only a few trials use the allocation concealment and blinded method, no description of comparability of baseline data, most of the trials do not report the inclusion and exclusion criteria, and none estimate the sample size. These problems indicate that it is necessary to improve the quality of clinical research in Chinese medicine and pharmacology.
The quality of reporting of randomized clinical trials could be significantly improved by the application of CONSORT （Consolidated Standards of Reporting Trials） statement. We compared and analyzed the difference of acceptance of CONSORT statement between Chinese medical journals and Western medical journals, and proposed to disseminate and apply CONSORT statement to improve the quality of reporting of randomized clinical trials and medical journals.
在临床干预试验中，运用随机分配是对照试验中控制偏倚和混杂的最佳工具。研究人员必须确保在试验报告中包含读者所需要的信息，以判断结果的有效性及其意义。事实上，完整的试验报告可让临床医生改进他们的临床实践，以反映当前最佳证据，并改善患者临床终点。制定 CONSORT 声明可协助研究人员、作者、审稿人及编辑了解临床试验报告中所需的必要信息。CONSORT 声明适用于任何干预措施，包括草药产品。当前草药干预措施的对照试验未充分报告 CONSORT 建议的信息条目。我们希望最近制定的 CONSORT 建议条目扩展版能更准确地报告草药干预措施随机对照试验，使其更加完整。我们编写的这份解释性文件除概述了每项建议的理由外，还提供了 CONSORT 条目和相关详细说明，并为每项建议提供了良好报告和经验证据的范例，以帮助作者能更好地运用它们。随着越来越多的证据积累和反馈意见的收集，这些有关草药产品临床试验报告的建议可随时进行修订。
ObjectiveTo evaluate the reporting quality of clinical randomized controlled trials (RCTs) published in five Chinese psychiatric journals from 2016 to 2020 and to compare the reporting quality with that from 2004 to 2008. MethodsRCTs in five Chinese psychiatric journals were collected through a computerized search of the CNKI, WanFang Data, and CBM databases and manual searches of paper journals, all with a search timeframe from 2016 to 2020. The CONSORT 2010 statement and two extensions (CONSORT extension for abstracts and CONSORT harms extension) were used to evaluate the RCTs. The criteria for reporting quality were the evaluation score, reporting proportion, and compliance proportion. The reporting quality of RCTs in the past 5 years was compared by year group. In addition, the RCT reporting quality from 2004 to 2008 was compared with that from 2016 to 2020. ResultsIn total, 226 RCTs were included. There was no statistically significant difference in the total evaluation score or abstract score from 2016 to 2020 (F=0.54, P=0.71; H=1.49, P=0.83). However, there were statistically significant differences in the harm scores from 2016 to 2020 (H=10.78, P=0.03). Further analysis of the items revealed statistically significant differences in the reporting proportion of items 16 and 19 (Fisher’s=8.61, P=0.04; χ2=11.63, P=0.02) and no significant differences in the other items (P>0.05). The reporting proportion of defined primary and secondary outcome indicators, allocation concealment, randomization implementation, outcomes and estimation, generalization, trial registration, and flow chart was <10% in each year. There was a statistically significant difference in the compliance proportion of RCT reporting quality from 2016 to 2020 versus 2004 to 2008 (39.54%±8.92% vs. 34.76%±9.16%, t=6.60, P<0.001). ConclusionThe reporting quality of RCTs in five Chinese psychiatric journals from 2016 to 2020 is better than that from 2004 to 2008. However, the reporting quality of RCTs within the latter 5 years still have reporting deficiencies in important items, and many aspects still are needed to be improved and enhanced.