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2010年至2019年以英文发表的中药随机对照试验:一项文献计量学研究。

Randomized controlled trials of Chinese herbal medicine published in English from 2010 to 2019: a bibliometrics study.

作者信息

Hu Jing, Zhang Hui-Na, Feng Shuo, Ha Yan-Xiang, Wei Chong-Yang, Wang Xue-Jiao, Zhang Rui, Li Bo

机构信息

Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Institute of Traditional Chinese Medicine, Beijing, China.

出版信息

Ann Palliat Med. 2021 Dec;10(12):12945-12954. doi: 10.21037/apm-20-1033. Epub 2021 Feb 11.

Abstract

BACKGROUND

As the use of Chinese herbal medicine (CHM) in the international market increases, the number of clinical studies including randomized controlled trials (RCTs) of CHM which published in international journals has also increased. Using bibliometrics, we systematically and comprehensively analyzed the research status of CHM RCTs published in English during the period of 2010 to 2019.

METHODS

Electronic searches in MEDLINE, EMBASE, and Cochrane Library databases were undertaken. CHM RCTs published in English between January 2010 and December 2019 were included. We randomly selected 20% from the eligible articles. Descriptive statistical analysis was carried out by extracting information on general information, characteristics of the study participants, interventions, outcomes, and risk of bias assessment of included RCTs.

RESULTS

Two hundred and twenty-seven CHM RCTs published in English were included in our study. Chinese Journal of Integrative Medicine was the journal which published most of the relevant papers (22.0%). A total of 45,774 participants were included, sample size ranged from 12 to 3,143 (median: 115). The most common disease was the circulatory diseases (n=36, 15.9%). Decoction was the most common dosage form (28.2%), and "CHM vs. placebo" was the most common type of control (36.1%). The median of the total number of outcomes was 4 (range, 1-14), 92 (40.5%) did not clearly specify any primary outcome, 56 (24.7%) did not report any adverse event, 41 (18.1%) and 68 (30.0%) reported traditional Chinese medicine (TCM)-specific outcomes and quality of life, respectively. Eighty-five (37.4%) did not report sufficient information about the random sequence generation process, 100 (44.1%) used the adequate allocation concealment, 92 (40.5%) blinded participants and key study personnel, and 24 (10.6%) blinded outcome assessors.

CONCLUSIONS

Our results provided insight into the research status regarding CHM RCTs published in English during the past decade, this study may be helpful in understanding research trends in this field.

摘要

背景

随着中药在国际市场上的使用增加,发表在国际期刊上的包括中药随机对照试验(RCT)在内的临床研究数量也有所增加。我们采用文献计量学方法,系统全面地分析了2010年至2019年期间以英文发表的中药RCT的研究现状。

方法

在MEDLINE、EMBASE和Cochrane图书馆数据库中进行电子检索。纳入2010年1月至2019年12月期间以英文发表的中药RCT。我们从符合条件的文章中随机抽取20%。通过提取纳入RCT的一般信息、研究参与者特征、干预措施、结局以及偏倚风险评估等信息进行描述性统计分析。

结果

本研究纳入了227篇以英文发表的中药RCT。《中国结合医学杂志》是发表相关论文最多的期刊(22.0%)。共纳入45774名参与者,样本量从12到3143不等(中位数:115)。最常见的疾病是循环系统疾病(n = 36,15.9%)。汤剂是最常见的剂型(28.2%),“中药与安慰剂对照”是最常见的对照类型(36.1%)。结局总数的中位数为4(范围1 - 14),92篇(40.5%)未明确指定任何主要结局,56篇(24.7%)未报告任何不良事件,41篇(18.1%)和68篇(30.0%)分别报告了中医特异性结局和生活质量。85篇(37.4%)未报告随机序列生成过程的充分信息,100篇(44.1%)采用了适当的分配隐藏,92篇(40.5%)对参与者和主要研究人员进行了盲法处理,24篇(10.6%)对结局评估者进行了盲法处理。

结论

我们的结果为过去十年以英文发表的中药RCT的研究现状提供了见解,本研究可能有助于了解该领域的研究趋势。

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