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. 2024 Sep;13(3):101053.
doi: 10.1016/j.imr.2024.101053. Epub 2024 May 31.

Using PRECIS-2 in Chinese herbal medicine randomized controlled trials for irritable bowel syndrome: A methodological exploration based on literature

Minjing Luo  1   2 , Yingqiao Wang  2 , Jinghan Huang  2 , Yilin Li  3 , Wenjie Li  2 , He Li  2 , Zhihan Liu  1   2 , Meijun Liu  1   2 , Yunci Tao  1   2 , Jianping Liu  1   2 , Yutong Fei  1   2
Affiliations

Using PRECIS-2 in Chinese herbal medicine randomized controlled trials for irritable bowel syndrome: A methodological exploration based on literature

Minjing Luo et al. Integr Med Res. 2024 Sep.

Abstract

Background: The pragmatism levels of randomized controlled trials (RCTs) mean how similar the interventions delivered in the trial setting match those in the setting where the results will be applied. We aimed to investigate the association between the consistency of pragmatism among the characteristics of RCT design and its effect size of results in Chinese herbal medicine (CHM) for irritable bowel syndrome (IBS).

Methods: Eight English and Chinese language databases were searched for RCTs on CHM for IBS. Six reviewers independently assessed the pragmatism of trials using the pragmatic-explanatory continuum indicator summary 2 (PRECIS-2) tool. The consistency of pragmatism levels among the characteristics of RCT design was calculated using the coefficient of variation. Linear regression models were adopted to explore influence factors of the pragmatism of RCTs.

Results: 78 RCTs were included. The level of consistency in the pragmatism for RCT's design was significantly correlated with the effect size of the results (binary outcome, r = -0.413; P = 0.005; continuous outcome, r = -0.779, P < 0.001). PRECIS-2 score was higher in trials with individualized interventions than fixed interventions (3.29 [0.32] vs 2.90 [0.32]; Cohen's d relative effect size, 0.52; P < 0.001) and in standard or usual-treatment-controlled trials than placebo-controlled (3.05 [0.37] vs 2.83 [0.28]; Cohen's d relative effect size, 0.32; P = 0.048).

Conclusion: The consistency of pragmatism level across the 9 domains of the PRECIS-2 tool in CHM IBS RCTs was positively correlated with the effect size of the results.

Keywords: Chinese herbal medicine (CHM); Irritable bowel syndrome (IBS); Methodological exploration; Pragmatic-explanatory continuum indicator summary 2 (PRECIS-2); Randomized controlled trial (RCT).

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Conflict of interest statement

The authors declare no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Fig. 1
Fig. 1
Flow diagram of the literature screening process.
Fig. 2
Fig. 2
Correlation trajectory between the coefficient of variation among the rating results on the 9 domains of PRECIS-2 tool in each trial and the effect size of each trial's result.
See this image and copyright information in PMC

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