Methodological project (SMART-PT) for transparency and methodological characteristics of randomized controlled trials of phytotherapy interventions

Cuncun Lu , Xiuxiu Deng , Ziyi Wang , Xiaoxiao Zhao , Lixin Ke , Zhifei Wang
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Abstract

Background

Randomized controlled trials (RCTs) are the gold standard for evaluating the efficacy and safety of medical interventions. Phytotherapy, which plays a critical role in the prevention and treatment of many clinical conditions, is also evaluated by RCTs. In recent years, the transparency, methodology, and generalizability of RCTs, as well as disparities in gender and geographical location among researchers, have attracted much attention from the scientific community. However, these aspects of RCTs in phytotherapy interventions have not been fully evaluated. Therefore, a methodological project (i.e., SMART-PT, tranSparency and Methodological chAracteristics of Randomized controlled Trials of PhytoTherapy interventions) was designed to overcome these knowledge gaps and provide key references for relevant future RCTs.

Methods

The SMART-PT project consists of five studies that will be conducted using RCTs derived from two high-impact phytotherapy journals, Phytomedicine and Phytotherapy Research. RCTs published in Phytomedicine and Phytotherapy Research were searched using the PubMed database from inception to February 13, 2023. Study selection was performed by two independent researchers, and data extraction and quality assessment will also be conducted independently by two researchers. First, we will investigate the reporting completeness, data-sharing level, and presence of spin among the included RCTs (Study 1). Second, we will evaluate the risk of bias in the included RCTs and the statistical fragility of primarily binary outcomes, and the likelihood ratio will be used to reinterpret statistically nonsignificant primary outcomes (Study 2). Third, we will evaluate the reporting completeness of phytotherapy interventions in the included RCTs as well as the trustworthiness of the RCTs (Study 3). Fourth, we will investigate the reporting of sociodemographic features and representation of participants in the included RCTs (Study 4). Finally, we will investigate the reporting completeness of the abstracts, the representation of gender, and geographical region of the listed authors among the included RCTs (Study 5). R 4.2.3, Stata 17/SE, and Excel 2019 will be used to analyze the data and create graphics.

Results and Discussion

One-hundred and fifty-two double-arm, parallel-group, superiority RCTs were included in the SMART-PT project. The results of the five meta-research studies will be submitted for publication in peer-reviewed journals.
植物疗法干预随机对照试验的透明度和方法学特征方法学项目(SMART-PT)
背景:随机对照试验(RCTs)是评价医学干预措施有效性和安全性的金标准。植物疗法在许多临床疾病的预防和治疗中起着关键作用,也通过随机对照试验进行评估。近年来,随机对照试验的透明度、方法学和普遍性以及研究人员在性别和地理位置上的差异引起了科学界的广泛关注。然而,这些方面的随机对照试验在植物疗法干预尚未得到充分评估。因此,我们设计了一个方法学项目(即SMART-PT,透明度和植物疗法干预随机对照试验的方法学特征)来克服这些知识空白,并为未来相关的随机对照试验提供关键参考。SMART-PT项目包括五项研究,将采用随机对照试验进行,这些随机对照试验来源于两本高影响力的植物疗法期刊《植物医学》和《植物疗法研究》。发表在《植物医学和植物疗法研究》上的随机对照试验使用PubMed数据库从创建到2023年2月13日进行检索。研究选择由两名独立研究人员进行,数据提取和质量评估也将由两名独立研究人员进行。首先,我们将调查纳入的rct的报告完整性、数据共享水平和自旋的存在(研究1)。其次,我们将评估纳入的rct的偏倚风险和主要二元结果的统计脆弱性,并使用似然比重新解释统计上不显著的主要结果(研究2)。我们将评估纳入的随机对照试验中植物疗法干预措施的报告完整性以及随机对照试验的可信度(研究3)。第四,我们将调查纳入的随机对照试验中社会人口学特征的报告和参与者的代表性(研究4)。最后,我们将调查纳入的随机对照试验中摘要的报告完整性、性别代表性和列出的作者的地理区域(研究5)。Excel 2019将用于分析数据和创建图形。结果与讨论SMART-PT项目共纳入152项双臂、平行组、优势随机对照试验。这五项元研究的结果将提交在同行评议的期刊上发表。
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