How fragile the positive results of Chinese herbal medicine randomized controlled trials on irritable bowel syndrome are?

Autor: Minjing Luo, Jinghan Huang, Yingqiao Wang, Yilin Li, Zhihan Liu, Meijun Liu, Yunci Tao, Rui Cao, Qianyun Chai, Jianping Liu, Yutong Fei
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: BMC Complementary Medicine and Therapies, Vol 24, Iss 1, Pp 1-12 (2024)
Druh dokumentu: article
ISSN: 2662-7671
DOI: 10.1186/s12906-024-04561-8
Popis: Abstract Objective The fragility index (FI), which is the minimum number of changes in status from “event” to “non-event” resulting in a loss of statistical significance, serves as a significant supplementary indicator for clinical physicians in interpreting clinical trial results and aids in understanding the outcomes of randomized controlled trials (RCTs). In this systematic literature survey, we evaluated the FI for RCTs evaluating Chinese herbal medicine (CHM) for irritable bowel syndrome (IBS), and explored potential associations between study characteristics and the robustness of RCTs. Methods A comprehensive search was conducted in four databases in Chinese and four databases in English from their inception to January 1, 2023. RCTs encompassed 1:1 ratio into two parallel arms and reported at least one binary outcome that demonstrated statistical significance were included. FI was calculated by the iterative reduction of a target outcome event in the treatment group and concomitant subtraction of a non-target event from that group, until positive significance (defined as P
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