中药治疗随机临床试验报告质量：2005 年至 2012 年中国知识基础设施数据库收录文章的系统评价。

The quality of reports of randomized clinical trials on traditional Chinese medicine treatments: a systematic review of articles indexed in the China National Knowledge Infrastructure database from 2005 to 2012.

机构信息

Department of Oncology, Fujian Academy of Integrative Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou 350112, PR China.

出版信息

BMC Complement Altern Med. 2014 Sep 26;14:362. doi: 10.1186/1472-6882-14-362.

DOI:10.1186/1472-6882-14-362

PMID:25256890

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4192762/

Abstract

BACKGROUND

The Consolidated Standards for Reporting Trials (CONSORT) are aimed to standardize clinical trial reporting. Our objective is to compare the quality of randomized clinical trials (RCTs) of traditional Chinese medicine (TCM) published in 2005-2009 and 2011-2012 according to the current CONSORT statements and Jadad scale.

DATA SOURCES

Reports on RCTs of TCM in the China National Knowledge Infrastructure database (CNKI database) for manuscripts published from 2005 to 2009 and 2011-2012. Search terms included TCM and clinical trial.

STUDY SELECTION

Manuscripts that reported RCTs of TCM were included.

DATA EXTRACTION

Independent extraction of articles was done by 3 authors. Disagreement was discussed until agreement was reached. According to the CONSORT checklist, an item was scored as 1 when the item was described in the paper. Otherwise the item was scored as 0.

RESULTS

A total of 4133 trials in 2005-2009 and 2861 trials in 2011-2012 were identified respectively. There was a significant increase in proportion of reports that included details of background (24.71% vs 35.20%, P < 0.001), participants (49.79% vs 65.26%, P < 0.001), the methods of random sequence generation (13.77% vs 19.85%, P < 0.001), statistical methods (63.00% vs 72.77%, P < 0.001) and recruitment date (70.14% vs 80.36%, P < 0.001) in 2011-2012 compared to 2005-2009. However, the percentage of reports with trial design decreased from 4.45% to 3.25% (P = 0.011). Few reports described the blinding methods, and there was a decreasing tendency (4.77% vs 2.48%, P < 0.001). There was a similar decreasing tendency on the reporting of funding (6.53% vs 5.00%, P = 0.007). There were no significant differences in the other CONSORT items. In terms of Jadad Score, the proportion of reports with a score of 2 was markedly increased (15.15% vs 19.71%, P < 0.001).

CONCLUSIONS

Although the quality of reporting RCTs of TCM was improved in 2011-2012 compared to 2005-2009, the percentages of high-quality reports are both very low in terms of Jadad score. There is a need for improving standards for reporting RCTs in China.

摘要

背景

《CONSORT 声明》旨在规范临床试验报告。我们的目的是根据当前的 CONSORT 声明和 Jadad 量表，比较 2005-2009 年和 2011-2012 年发表的中医药随机对照试验（RCT）的质量。

数据来源

中国国家知识基础设施数据库（CNKI 数据库）中 2005 年至 2009 年和 2011-2012 年发表的中医药 RCT 报告。检索词包括中医药和临床试验。

研究选择

纳入报告中医药 RCT 的论文。

数据提取

由 3 位作者独立提取文章。有分歧的地方进行了讨论，直到达成一致。根据 CONSORT 清单，如果项目在论文中有描述，则项目得分为 1，否则项目得分为 0。

结果

2005-2009 年共鉴定出 4133 项试验，2011-2012 年鉴定出 2861 项试验。2011-2012 年报告中包含背景（24.71%比 35.20%，P <0.001）、参与者（49.79%比 65.26%，P <0.001）、随机序列生成方法（13.77%比 19.85%，P <0.001）、统计方法（63.00%比 72.77%，P <0.001）和招募日期（70.14%比 80.36%，P <0.001）的报告比例显著增加。然而，试验设计的报告比例从 4.45%降至 3.25%（P = 0.011）。很少有报告描述了盲法，且有下降趋势（4.77%比 2.48%，P <0.001）。报告资金的比例也有类似的下降趋势（6.53%比 5.00%，P = 0.007）。其他 CONSORT 项目无显著差异。在 Jadad 评分方面，得分为 2 的报告比例显著增加（15.15%比 19.71%，P <0.001）。