| アブストラクト | ETHNOPHARMACOLOGICAL RELEVANCE: Senna, a medicinal plant widely utilized across the globe and classified within the leguminous family, is traditionally characterized by its sweet, bitter, and cold properties and is associated with the large intestine meridian in various traditional medicine systems. It is renowned for its therapeutic properties, including its abilities to purge heat, alleviate stagnation, relax the bowels, and induce diuresis. Despite its prevalent use for its laxative effects, the safety profile and potential adverse events (AEs) associated with senna remain inadequately explored, particularly within the realm of pharmacovigilance. AIM OF THE STUDY: This study seeks to analyze the adverse events associated with senna as reported in the FDA Adverse Event Reporting System (FAERS) from 2004 to 2024. It aims to evaluate the strength of the signals for these adverse events and to identify potential risk factors. MATERIALS AND METHODS: Data were sourced from the FAERS database, comprising 21,890,177 reports related to senna. Following the removal of duplicate entries, a total of 18,282,801 reports were subjected to analysis for adverse events (AEs), categorized according to the System Organ Class (SOC) and Preferred Term (PT) levels. Disproportionality analyses were conducted utilizing algorithms including the reporting odds ratio (ROR), proportionate reporting ratio (PRR), information component (IC), and empirical Bayes geometric mean (EBGM). To identify significant risk factors, time-to-onset (TTO) analysis and logistic regression were applied. Furthermore, the modified Bradford Hill criteria were employed to assess global causal relationships, examining elements such as the strength of association, analogy, consistency, biological plausibility, and temporality to determine potential causal links between senna use and AEs. RESULTS: The study identified a significant increase in reported AEs over the study period, with the highest incidence observed in 2024 (n=423). Immune system disorders were the most frequently reported system organ class (SOC) (n=1722), followed by gastrointestinal disorders and hypersensitivity reactions. Females constituted 62.86% of the reported AEs, while individuals aged over 60 years accounted for 32.09% of cases. The majority of AEs occurred within the first week of treatment, with a median onset time of 4 days. Logistic regression analysis identified several independent risk factors for immune system disorders, including advanced age, female sex, and the use of concomitant medications such as ascorbic acid and tofacitinib citrate. The global assessment indicated that multiple Bradford Hill criteria were satisfied, suggesting a plausible causal relationship. CONCLUSIONS: The findings suggest a potential link between senna use and immune system disorders, highlighting the need for careful monitoring of its safety profile in clinical practice. Further research is necessary to elucidate the mechanisms underlying these adverse reactions. |
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| 投稿者 | Zhao, Jingyi; Chen, Yan; Du, Chao; Zhang, Wenhui; Liu, Wei; Chen, Jingwen; Ma, Shuai; Yao, Yinhui |
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| 組織名 | Hebei (Chengde) Industrial Technology Institute of Chinese Medicinal Materials,;Chengde Medical University, Chengde, 067000, China.;School of Basic Medicine, Chengde Medical University, Chengde, 067000, China.;Chengde Medical University, Chengde, 067000, China. Electronic address:;630853162@qq.com.;Department of Pharmacy, the Affiliated Hospital of Chengde Medical University,;Chengde, 067000, China. Electronic address: yaoyh_gc@163.com. |
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