Blinding assessment in clinical trials of traditional Chinese medicine: Exploratory principles and protocol.

As one of the key components of clinical trials, blinding, if successfully implemented, can help to mitigate the risks of implementation bias and measurement bias, consequently improving the validity and reliability of the trial results. However, successful blinding in clinical trials of traditional Chinese medicine (TCM) is hard to achieve, and the evaluation of blinding success through blinding assessment lacks established guidelines. Taking into account the challenges associated with blinding in the TCM field, here we present a framework for assessing blinding. Further, this study proposes a blinding assessment protocol for TCM clinical trials, building upon the framework and the existing methods. An assessment report checklist and an approach for evaluating the assessment results are presented based on the proposed protocol. It is anticipated that these improvements to blinding assessment will generate greater awareness among researchers, facilitate the standardization of blinding, and augment the blinding effectiveness. The use of this blinding assessment may further advance the quality and precision of TCM clinical trials and improve the accuracy of the trial results. The blinding assessment protocol will undergo continued optimization and refinement, drawing upon expert consensus and experience derived from clinical trials. Please cite this article as: Wang XC, Liu XY, Shi KL, Meng QG, Yu YF, Wang SY, Wang J, Qu C, Lei C, Yu XP. Blinding assessment in clinical trials of traditional Chinese medicine: Exploratory principles and protocol. J Integr Med. 2023; 21(6): 528-536.

[Analysis on the Current Situation of Phytoplankton in the Typical River-Lake Ecotone of Lake Poyang].

The typical river-lake ecotone (tail end area) of Poyang Lake, which is a sensitive area and prone to outbreaks of cyanobacteria bloom, is vulnerable to frequent human activities. To explore the diversity of phytoplankton community structure and the relevant driving mechanism in the typical river lake junction area of Poyang Lake, the water quality and phytoplankton at seven sampling points in the typical river lake junction area of Poyang Lake, at six sampling points in the middle section of Poyang Lake River, and at one sampling point in the main lake area were investigated in the field from 2019 to 2020 (dry season), April (flood season), July (wet season), and October (recession period). The results showed that there were seven phyla and 64 genera of phytoplankton in the typical river-lake ecotone of Poyang Lake, and the biomass and relative abundance of phytoplankton were dominated by diatoms and cyanobacteria. The biomass and abundance in the east of the typical river-lake ecotone of Poyang Lake were generally higher than those in the west, and the biomass and abundance in the river-lake ecotone were higher than those in the middle of the river. The dominant degree of cyanobacteria in the lake area and the river-lake ecotone was large, and the dominant degree of diatoms in the middle section of the river was large. The Monte Carlo test results showed that total nitrogen (TN), total phosphorus (TP), orthophosphate phosphorus (PO43--P), water depth (WD), water temperature (WT), and transparency (SD) were significantly related environmental factors affecting the distribution of the phytoplankton community. Redundancy analysis results showed that the typical river-lake ecotone in the west of Poyang Lake was highly affected by the hydration factors (TN, TP, and PO43--P), and the hydrological factors (WT, WD, and SD) in the typical river-lake ecotone in the east were highly significant. The impact factors of phytoplankton in the typical river-lake ecotone of Poyang Lake were seasonal, being greatly affected by hydration factors in winter and hydrological factors in summer.