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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2021
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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) |
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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 |
work_keys_str_mv |
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