A synthesis of the evidence regarding safety of a Chinese herbal formula Shufeng Jiedu: A pharmacological review
A synthesis of the evidence regarding safety of a Chinese herbal formula Shufeng Jiedu: A pharmacological review
Shufeng Jiedu capsule (SFJDC) is a Chinese herbal medicine formula for treating acute respiratory tract infections. This review aims to assess its potential safety for clinical setting. Systematic literature searches were conducted across multiple databases to: investigate the phytochemistry and safety data on SFJD and its constituents; and to produce a meta-analysis of RCTs reporting safety concerns (all ages) receiving SFJDC capsule (any condition). The primary outcome was the incidence of adverse events (AEs) or complications associated with taking SFJDC with/without usual care compared with placebo or usual care. Pharmacovigilance data reporting AEs to the Chinese National Adverse Drug Reaction Monitoring System in 2017/2018 was analysed. Safety information was insufficient regarding pregnancy/lactation (all herbs). Laboratory studies raised theoretical concerns regarding saikosaponins A and D elevating blood glucose; glycyrrhizin inducing hypertension and hypokalaemia; and saikosaponins/resveratrol/lignans reducing platelet activity. However, these occurred at much higher doses than used clinically. Sixty-four RCTs (7612 participants) met the meta-analysis criteria. Fourteen additional trials and two case studies were also considered. Minor AEs included nausea/vomiting, diarrhoea, unspecified gastrointestinal discomfort, dizziness and rash; these were not significantly different (statistically) to control groups. Across 2017 and 2018 sales of SFJDC packs (content 36 capsules) totalled 23.2 million. AEs recorded were 169 (2017) and 198 (2018). The majority were gastrointestinal, and improved on stopping SFJDC. None included the potential phytochemical concerns (regarding platelets, hypertension, hypokalaemia, blood glucose). No serious AEs were identified from the included trials or pharmacovigilance data. No substantive safety concerns were identified for SFJD for clinical use; excluding pregnant/lactating women.
Adverse event, Herbal medicine, Meta-analysis, Safety, Shufeng Jiedu, Side effect
Trill, Jeanne
65ee5141-abbb-4389-9bd1-5da6199a26cb
Wang, Zhijie
5d191904-f06c-4f12-b3b6-0e0053661a1e
Willcox, Merlin
dad5b622-9ac2-417d-9b2e-aad41b64ffea
Zhang, Yu
a851ce00-2181-4b85-bb62-50fcbee83a95
Hu, Xiao Yang
65904b24-3775-4b14-9532-eb703a056655
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
March 2022
Trill, Jeanne
65ee5141-abbb-4389-9bd1-5da6199a26cb
Wang, Zhijie
5d191904-f06c-4f12-b3b6-0e0053661a1e
Willcox, Merlin
dad5b622-9ac2-417d-9b2e-aad41b64ffea
Zhang, Yu
a851ce00-2181-4b85-bb62-50fcbee83a95
Hu, Xiao Yang
65904b24-3775-4b14-9532-eb703a056655
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Trill, Jeanne, Wang, Zhijie, Willcox, Merlin, Zhang, Yu, Hu, Xiao Yang and Moore, Michael
(2022)
A synthesis of the evidence regarding safety of a Chinese herbal formula Shufeng Jiedu: A pharmacological review.
Pharmacological Research - Modern Chinese Medicine, 2, [100017].
(doi:10.1016/j.prmcm.2021.100017).
Abstract
Shufeng Jiedu capsule (SFJDC) is a Chinese herbal medicine formula for treating acute respiratory tract infections. This review aims to assess its potential safety for clinical setting. Systematic literature searches were conducted across multiple databases to: investigate the phytochemistry and safety data on SFJD and its constituents; and to produce a meta-analysis of RCTs reporting safety concerns (all ages) receiving SFJDC capsule (any condition). The primary outcome was the incidence of adverse events (AEs) or complications associated with taking SFJDC with/without usual care compared with placebo or usual care. Pharmacovigilance data reporting AEs to the Chinese National Adverse Drug Reaction Monitoring System in 2017/2018 was analysed. Safety information was insufficient regarding pregnancy/lactation (all herbs). Laboratory studies raised theoretical concerns regarding saikosaponins A and D elevating blood glucose; glycyrrhizin inducing hypertension and hypokalaemia; and saikosaponins/resveratrol/lignans reducing platelet activity. However, these occurred at much higher doses than used clinically. Sixty-four RCTs (7612 participants) met the meta-analysis criteria. Fourteen additional trials and two case studies were also considered. Minor AEs included nausea/vomiting, diarrhoea, unspecified gastrointestinal discomfort, dizziness and rash; these were not significantly different (statistically) to control groups. Across 2017 and 2018 sales of SFJDC packs (content 36 capsules) totalled 23.2 million. AEs recorded were 169 (2017) and 198 (2018). The majority were gastrointestinal, and improved on stopping SFJDC. None included the potential phytochemical concerns (regarding platelets, hypertension, hypokalaemia, blood glucose). No serious AEs were identified from the included trials or pharmacovigilance data. No substantive safety concerns were identified for SFJD for clinical use; excluding pregnant/lactating women.
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More information
Accepted/In Press date: 14 October 2021
e-pub ahead of print date: 3 December 2021
Published date: March 2022
Additional Information:
Funding Information:
This study was funded by Innovate UK (grant no. 104287-610239 ) and the National Key Research and Development Project (grant no. 2018YFE0102300 ).
Publisher Copyright:
© 2021
Keywords:
Adverse event, Herbal medicine, Meta-analysis, Safety, Shufeng Jiedu, Side effect
Identifiers
Local EPrints ID: 481359
URI: http://eprints.soton.ac.uk/id/eprint/481359
PURE UUID: be2bf9f2-1965-4291-8077-6ee7b10967d0
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Date deposited: 23 Aug 2023 17:06
Last modified: 18 Mar 2024 03:39
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Contributors
Author:
Jeanne Trill
Author:
Zhijie Wang
Author:
Yu Zhang
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