A system for reporting and evaluating adverse drug reactions of herbal medicine in Taiwan from 1998 to 2016

Abstract The Taiwan Adverse Drug Reaction Reporting System for Herbal Medicine (TADRRS-HM) has systematically documented suspected adverse events from adverse drug reaction (ADR) reports from 1998 (prior to its formal establishment in 2001) and evaluates safety profiles of herbal medicines. This art...

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Autores principales: Hen-Hong Chang, Su-Yin Chiang, Pei-Chun Chen, Chia-Han Tsai, Rong-Chi Yang, Chiu-Lin Tsai, Tsung-hsiu Wu, Yow-Wen Hsieh, Yu-Chun Lin, Yung-Te Kuo, Kuan-Chung Chen, Hsueh-Ting Chu
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Publicado: Nature Portfolio 2021
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Acceso en línea:https://doaj.org/article/d97dcb13d0fa4431abe2a3b0c45fd768
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spelling oai:doaj.org-article:d97dcb13d0fa4431abe2a3b0c45fd7682021-11-08T10:52:28ZA system for reporting and evaluating adverse drug reactions of herbal medicine in Taiwan from 1998 to 201610.1038/s41598-021-00704-w2045-2322https://doaj.org/article/d97dcb13d0fa4431abe2a3b0c45fd7682021-11-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-00704-whttps://doaj.org/toc/2045-2322Abstract The Taiwan Adverse Drug Reaction Reporting System for Herbal Medicine (TADRRS-HM) has systematically documented suspected adverse events from adverse drug reaction (ADR) reports from 1998 (prior to its formal establishment in 2001) and evaluates safety profiles of herbal medicines. This article describes findings from 2079 ADR reports filed between 1998 and 2016: 941 reports involved single herbs and 87 involved folk herbals; 842 were generated from clinical trials, while 209 ADR reports involving foods, health foods, dietary supplement foods and herbal cuisine were grouped as Other. Severity assessments using the Modified Hartwig and Siegel scale classified 72.4% of ADRs as mild, 17.4% as moderate and 6.5% as severe. System Organ Class classification of the ADRs identified gastrointestinal system disorders as the most common (33.4%), followed by skin and subcutaneous tissue disorders (21.2%). The TADRRS-HM records indicate that herbal medicines may cause a wide range of ADRs. Aconiti Radix, Xiao-Qing-Long-Tang, and Datura suaveolens were the most commonly reported single herb, herbal formula, and folk herbal, respectively. The data indicate that herbal medicines may cause a wide range of ADRs. This system will confer long-term benefits for the development of Taiwan’s herbal medicines adverse reaction database and facilitate epidemiological analysis.Hen-Hong ChangSu-Yin ChiangPei-Chun ChenChia-Han TsaiRong-Chi YangChiu-Lin TsaiTsung-hsiu WuYow-Wen HsiehYu-Chun LinYung-Te KuoKuan-Chung ChenHsueh-Ting ChuNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-11 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
Hen-Hong Chang
Su-Yin Chiang
Pei-Chun Chen
Chia-Han Tsai
Rong-Chi Yang
Chiu-Lin Tsai
Tsung-hsiu Wu
Yow-Wen Hsieh
Yu-Chun Lin
Yung-Te Kuo
Kuan-Chung Chen
Hsueh-Ting Chu
A system for reporting and evaluating adverse drug reactions of herbal medicine in Taiwan from 1998 to 2016
description Abstract The Taiwan Adverse Drug Reaction Reporting System for Herbal Medicine (TADRRS-HM) has systematically documented suspected adverse events from adverse drug reaction (ADR) reports from 1998 (prior to its formal establishment in 2001) and evaluates safety profiles of herbal medicines. This article describes findings from 2079 ADR reports filed between 1998 and 2016: 941 reports involved single herbs and 87 involved folk herbals; 842 were generated from clinical trials, while 209 ADR reports involving foods, health foods, dietary supplement foods and herbal cuisine were grouped as Other. Severity assessments using the Modified Hartwig and Siegel scale classified 72.4% of ADRs as mild, 17.4% as moderate and 6.5% as severe. System Organ Class classification of the ADRs identified gastrointestinal system disorders as the most common (33.4%), followed by skin and subcutaneous tissue disorders (21.2%). The TADRRS-HM records indicate that herbal medicines may cause a wide range of ADRs. Aconiti Radix, Xiao-Qing-Long-Tang, and Datura suaveolens were the most commonly reported single herb, herbal formula, and folk herbal, respectively. The data indicate that herbal medicines may cause a wide range of ADRs. This system will confer long-term benefits for the development of Taiwan’s herbal medicines adverse reaction database and facilitate epidemiological analysis.
format article
author Hen-Hong Chang
Su-Yin Chiang
Pei-Chun Chen
Chia-Han Tsai
Rong-Chi Yang
Chiu-Lin Tsai
Tsung-hsiu Wu
Yow-Wen Hsieh
Yu-Chun Lin
Yung-Te Kuo
Kuan-Chung Chen
Hsueh-Ting Chu
author_facet Hen-Hong Chang
Su-Yin Chiang
Pei-Chun Chen
Chia-Han Tsai
Rong-Chi Yang
Chiu-Lin Tsai
Tsung-hsiu Wu
Yow-Wen Hsieh
Yu-Chun Lin
Yung-Te Kuo
Kuan-Chung Chen
Hsueh-Ting Chu
author_sort Hen-Hong Chang
title A system for reporting and evaluating adverse drug reactions of herbal medicine in Taiwan from 1998 to 2016
title_short A system for reporting and evaluating adverse drug reactions of herbal medicine in Taiwan from 1998 to 2016
title_full A system for reporting and evaluating adverse drug reactions of herbal medicine in Taiwan from 1998 to 2016
title_fullStr A system for reporting and evaluating adverse drug reactions of herbal medicine in Taiwan from 1998 to 2016
title_full_unstemmed A system for reporting and evaluating adverse drug reactions of herbal medicine in Taiwan from 1998 to 2016
title_sort system for reporting and evaluating adverse drug reactions of herbal medicine in taiwan from 1998 to 2016
publisher Nature Portfolio
publishDate 2021
url https://doaj.org/article/d97dcb13d0fa4431abe2a3b0c45fd768
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