Adverse Effects of Andrographolide Derivative Medications Compared to the Safe use of Herbal Preparations of Andrographis paniculata: Results of a Systematic Review and Meta-Analysis of Clinical Studies
Background and objective:Andrographis paniculata (AP) is a traditionally used herbaceous plant, whose main active constituent is andrographolide. Andrographolide derivative medications and herbal preparations of AP are often used to treat respiratory tract infections. This study aims to systematical...
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Frontiers Media S.A.
2022-01-01
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| Series: | Frontiers in Pharmacology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fphar.2022.773282/full |
| _version_ | 1818954156136726528 |
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| author | Ya-xi Shang Chen Shen Trine Stub Si-jia Zhu Shu-yu Qiao Yu-qi Li Rui-ting Wang Jing Li Jian-ping Liu |
| author_facet | Ya-xi Shang Chen Shen Trine Stub Si-jia Zhu Shu-yu Qiao Yu-qi Li Rui-ting Wang Jing Li Jian-ping Liu |
| author_sort | Ya-xi Shang |
| collection | DOAJ |
| description | Background and objective:Andrographis paniculata (AP) is a traditionally used herbaceous plant, whose main active constituent is andrographolide. Andrographolide derivative medications and herbal preparations of AP are often used to treat respiratory tract infections. This study aims to systematically evaluate the safety of andrographolide derivative medications and herbal preparations of AP based on clinical studies.Methods: English and Chinese databases were searched for all types of clinical studies that reported adverse drug reactions (ADRs) and adverse events (AEs) of andrographolide derivative medications and herbal preparations of AP. The ADRs and AEs were classified according to manifestations, and graded according to severity. Single-rate meta-analysis was performed for ADR incidence using R software.Results: A total of 262 studies were included, including 125 randomized controlled trials, 23 non-randomized controlled trials, 6 case series, and 108 case reports. In 9490 participants using andrographolide derivative injections, 383 (4.04%) reported ADRs. Meta-analysis showed that the ADR incidence of three most frequently used injections of andrographolide derivatives (andrographolide sulfonate, potassium sodium dehydroandrographolide succinate, and potassium dehydroandrographolide succinate) were 5.48% [95% CI (4.47%, 6.72%)], 3.69% [95% CI (2.59%, 4.94%)] and 5.33% [95% CI (3.68%, 7.72%)], respectively, which may be slightly higher than the actual ADR incidence, because only studies that reported the occurrence of ADRs or AEs were included, but studies without ADR and AE were not included. The ADRs of andrographolide derivative injections were mainly gastrointestinal, skin and subcutaneous tissue disorders, and anaphylaxis. Fifty-five patients experienced life-threatening anaphylactic shock, three patients died, and the causation attributed to the andrographolide derivative injection. Other ADRs were mild, moderate or medically significant. Nine herbal preparations of AP were tested in 10 studies, and the reported ADRs were mainly mild to moderate gastrointestinal, skin and subcutaneous tissue disorders. Except for five patients using andrographolide derivative injections eventually died, most of the ADRs were alleviated after drug withdrawal and symptomatic treatment.Conclusions: The ADRs of andrographolide derivative medications are few, but can be life-threatening, mainly gastrointestinal, skin and subcutaneous tissue disorders, and anaphylaxis. Injections of andrographolide derivatives should be used with caution. Herbal preparations of AP are essentially safe.Systematic Review Registration: [website], identifier [registration number] |
| first_indexed | 2024-12-20T10:17:41Z |
| format | Article |
| id | doaj.art-89660fc300ac484dacc856290c808e17 |
| institution | Directory Open Access Journal |
| issn | 1663-9812 |
| language | English |
| last_indexed | 2024-12-20T10:17:41Z |
| publishDate | 2022-01-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Pharmacology |
| spelling | doaj.art-89660fc300ac484dacc856290c808e172022-12-21T19:44:01ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122022-01-011310.3389/fphar.2022.773282773282Adverse Effects of Andrographolide Derivative Medications Compared to the Safe use of Herbal Preparations of Andrographis paniculata: Results of a Systematic Review and Meta-Analysis of Clinical StudiesYa-xi Shang0Chen Shen1Trine Stub2Si-jia Zhu3Shu-yu Qiao4Yu-qi Li5Rui-ting Wang6Jing Li7Jian-ping Liu8Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaThe National Research Center in Complementary and Alternative Medicine (NAFKAM), Department of Community Medicine, Faculty of Health Science, UiT, The Arctic University of Norway, Tromsø, NorwayCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaDongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, ChinaBeijing Key Laboratory of the Innovative Development of Functional Staple and the Nutritional Intervention for Chronic Disease, China National Research Institute of Food and Fermentation Industries Co, Ltd., Beijing, ChinaCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing, ChinaBackground and objective:Andrographis paniculata (AP) is a traditionally used herbaceous plant, whose main active constituent is andrographolide. Andrographolide derivative medications and herbal preparations of AP are often used to treat respiratory tract infections. This study aims to systematically evaluate the safety of andrographolide derivative medications and herbal preparations of AP based on clinical studies.Methods: English and Chinese databases were searched for all types of clinical studies that reported adverse drug reactions (ADRs) and adverse events (AEs) of andrographolide derivative medications and herbal preparations of AP. The ADRs and AEs were classified according to manifestations, and graded according to severity. Single-rate meta-analysis was performed for ADR incidence using R software.Results: A total of 262 studies were included, including 125 randomized controlled trials, 23 non-randomized controlled trials, 6 case series, and 108 case reports. In 9490 participants using andrographolide derivative injections, 383 (4.04%) reported ADRs. Meta-analysis showed that the ADR incidence of three most frequently used injections of andrographolide derivatives (andrographolide sulfonate, potassium sodium dehydroandrographolide succinate, and potassium dehydroandrographolide succinate) were 5.48% [95% CI (4.47%, 6.72%)], 3.69% [95% CI (2.59%, 4.94%)] and 5.33% [95% CI (3.68%, 7.72%)], respectively, which may be slightly higher than the actual ADR incidence, because only studies that reported the occurrence of ADRs or AEs were included, but studies without ADR and AE were not included. The ADRs of andrographolide derivative injections were mainly gastrointestinal, skin and subcutaneous tissue disorders, and anaphylaxis. Fifty-five patients experienced life-threatening anaphylactic shock, three patients died, and the causation attributed to the andrographolide derivative injection. Other ADRs were mild, moderate or medically significant. Nine herbal preparations of AP were tested in 10 studies, and the reported ADRs were mainly mild to moderate gastrointestinal, skin and subcutaneous tissue disorders. Except for five patients using andrographolide derivative injections eventually died, most of the ADRs were alleviated after drug withdrawal and symptomatic treatment.Conclusions: The ADRs of andrographolide derivative medications are few, but can be life-threatening, mainly gastrointestinal, skin and subcutaneous tissue disorders, and anaphylaxis. Injections of andrographolide derivatives should be used with caution. Herbal preparations of AP are essentially safe.Systematic Review Registration: [website], identifier [registration number]https://www.frontiersin.org/articles/10.3389/fphar.2022.773282/fullAndrographis paniculataandrographolidedrug safetyadverse drug reactionadverse eventclinical study |
| spellingShingle | Ya-xi Shang Chen Shen Trine Stub Si-jia Zhu Shu-yu Qiao Yu-qi Li Rui-ting Wang Jing Li Jian-ping Liu Adverse Effects of Andrographolide Derivative Medications Compared to the Safe use of Herbal Preparations of Andrographis paniculata: Results of a Systematic Review and Meta-Analysis of Clinical Studies Frontiers in Pharmacology Andrographis paniculata andrographolide drug safety adverse drug reaction adverse event clinical study |
| title | Adverse Effects of Andrographolide Derivative Medications Compared to the Safe use of Herbal Preparations of Andrographis paniculata: Results of a Systematic Review and Meta-Analysis of Clinical Studies |
| title_full | Adverse Effects of Andrographolide Derivative Medications Compared to the Safe use of Herbal Preparations of Andrographis paniculata: Results of a Systematic Review and Meta-Analysis of Clinical Studies |
| title_fullStr | Adverse Effects of Andrographolide Derivative Medications Compared to the Safe use of Herbal Preparations of Andrographis paniculata: Results of a Systematic Review and Meta-Analysis of Clinical Studies |
| title_full_unstemmed | Adverse Effects of Andrographolide Derivative Medications Compared to the Safe use of Herbal Preparations of Andrographis paniculata: Results of a Systematic Review and Meta-Analysis of Clinical Studies |
| title_short | Adverse Effects of Andrographolide Derivative Medications Compared to the Safe use of Herbal Preparations of Andrographis paniculata: Results of a Systematic Review and Meta-Analysis of Clinical Studies |
| title_sort | adverse effects of andrographolide derivative medications compared to the safe use of herbal preparations of andrographis paniculata results of a systematic review and meta analysis of clinical studies |
| topic | Andrographis paniculata andrographolide drug safety adverse drug reaction adverse event clinical study |
| url | https://www.frontiersin.org/articles/10.3389/fphar.2022.773282/full |
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