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

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.

Keywords

• Phytotherapy
• Transparency
• Trustworthiness
• Statistical significance
• Gender
• Protocol