针灸临床试验报道是否规范

笑湖

针灸临床试验报道是否规范2016-07-14 孙元杰 陈波 编制

“随机对照临床试验报告规范”和“针刺临床试验干预措施报告标准”能否提升中文文献报道针灸随机对照试验水准的系统综述及分析

Abstract

Background

We investigated whether there had been an improvement in the quality of reporting for randomised controlled trials of acupuncture and moxibustion published in Chinese journals. We compared the compliance rate for the quality of reporting following the publication of both the STRICTA and CONSORT recommendations in China.

Methods

Four Chinese databases were searched for RCTs of acupuncture from January 1978 through to December 2012. The CONSORT and STRICTA checklists were used to assess the quality of reporting. 从中文数据库中筛选从1978年一月份到2012年12月份中所有的针刺随机对照临床试验，并运用CONSORT和STRICTA对文章的质量进行评估。Data were collected using a standardised form. All included RCTs were divided into three distinct time periods based on the time that CONSORT and STRICTA were introduced in China, respectively. Pearson's χ2 test and/or Fisher's exact test were used to assess differences in reporting among three groups.

Principal Findings

A total of 1978 RCTs were identified. Although the percentage of all the items has increased over time with the introduction of CONSORT and STRICTA in China, the actual compliance in several important methodological components, including sample size calculation (0% vs. 0% vs. 1.2%, for pre-CONSORT and pre-STRICTA, post-CONSORT but pre-STRICTA, and post-CONSORT and post-STRICTA, respectively), randomisation sequence generation (1.4% vs. 15% vs. 26.3%) and implementation (0% vs. 0% vs. 1.3%), allocation concealment (0% vs. 1.4% vs. 4.9%), and blinding (0% vs. 5.7% vs. 9.1%), remains low. Moreover, no RCTs have reported the setting and context of treatment and no descriptions of the participating acupuncturists have been provided thus far.

Conclusions

Overall, the quality of the reporting of RCTs of acupuncture and moxibustion published in Chinese journals has improved since CONSORT and STRICTA were introduced in China, CONSORT 和 STRICTA使国内期刊报道针灸随机对照试验质量有所提升though the actual compliance rate of some important items were still low as of 2012. In the future, Chinese journals should enhance the adoption of the CONSORT and STRICTA statement to improve the reporting quality of the RCTs of acupuncture and moxibustion and to ensure the truth and reliability of the conclusions.

小编按：

一、什么是CONSORT？

CONSORT是Consohdated Standards of Reporting Trials 的简称，是一个随机对照临床试验报告的规范。该规范完成于20世纪90年代中期，由一个包括临床流行病学家、临床专业人员、统计学家和医学杂志编辑在内的课题组，花费近2年的时间制作而成，并在国际著名的临床医学杂志上得以应用。

有关Consort声明的详细信息可从该网站进行获取：http://www.consort-statement.org

二、什么是STRICTA?

          此处引用李幼平教授等所执笔的一篇文献来进行说明，在此对李幼平教    授等人表示感谢。

有关STRICTA的详细信息可从该网站进行获取：http://www.stricta.info/