Efficacy and safety of Chinese patent medicines for allergic rhinitis based on 2020 Chinese Pharmacopoeia: a protocol for systematic review and meta-analysis of randomized controlled trials

Abstract Background Allergic Rhinitis (AR) is a prevalent chronic respiratory condition with limited long-term relief from Western medications. Interest in Traditional Chinese Patent Medicines (TCPMs) as a complementary approach is growing, but research on their efficacy and safety is lacking. We ai...

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Main Authors: Weibo Zhao, Lingyao Kong, Xuehui Wang, Qingyuan Liu, Yaqi Wang, Ji Wang
Format: Article
Language:English
Published: BMC 2025-03-01
Series:Systematic Reviews
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Online Access:https://doi.org/10.1186/s13643-024-02748-1
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author Weibo Zhao
Lingyao Kong
Xuehui Wang
Qingyuan Liu
Yaqi Wang
Ji Wang
author_facet Weibo Zhao
Lingyao Kong
Xuehui Wang
Qingyuan Liu
Yaqi Wang
Ji Wang
author_sort Weibo Zhao
collection DOAJ
description Abstract Background Allergic Rhinitis (AR) is a prevalent chronic respiratory condition with limited long-term relief from Western medications. Interest in Traditional Chinese Patent Medicines (TCPMs) as a complementary approach is growing, but research on their efficacy and safety is lacking. We aim to evaluate the efficacy and safety of TCPMs listed in the 2020 Chinese Pharmacopoeia (ChP 2020) that are indicated for treating AR. Methods We will search PubMed, Embase, Web of Science, Cochrane Library, and four Chinese databases to retrieve randomized controlled trials investigating specific TCPMs (Biyankang tablets, Tongqiao Biyan Granules, Tongqiao Biyan Tablets, Tongqiao Biyan Capsules, Xinqin Granules, Xinqin Tablets, Xinyi Biyan Pills) for AR. Primary outcomes are Total Nasal Symptom Scores (TNSS) and Total Ocular Symptom Scores (TOSS). Secondary outcomes include quality of life, relapse rates, nasal function, biomarkers, and adverse events. No languages and publication data limitations. Meta-analysis will be performed using RevMan 5.4 with random effects model. Publication bias are set to be assessed using funnel plots and Egger’s test, and adjusted with the trim and fill method. Meta-regression will investigate factors influencing outcomes for AR. Study quality will be assessed using the Cochrane Risk of Bias 2.0 tool, and the Grading of Recommendations Assessment, Development, and Evaluation approach will be used to evaluate the quality of evidence. Discussion Despite the limitations of conventional AR medications, TCPMs show potential benefits in immune modulation and symptom relief. This review will focus on TCPMs listed in ChP 2020 to comprehensively evaluate their safety and efficacy for AR. Unlike existing reviews, this study emphasizes rigorous standards of TCPMs, aiming to provide a more reliable evidence base. Although a network meta-analysis would be ideal, a traditional meta-analysis will be conducted due to limited data. Future research should focus on direct comparative studies and utilize AI techniques for understanding mechanisms and enhancing personalized treatments. This review aims to bridge gaps in the current literature and potentially improve clinical guidelines and patient outcomes in AR management. Systematic review registration INPLASY202450121.
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spelling doaj-art-97d5ef133c134a4491d37e6a7bf101632025-08-20T02:49:29ZengBMCSystematic Reviews2046-40532025-03-011411810.1186/s13643-024-02748-1Efficacy and safety of Chinese patent medicines for allergic rhinitis based on 2020 Chinese Pharmacopoeia: a protocol for systematic review and meta-analysis of randomized controlled trialsWeibo Zhao0Lingyao Kong1Xuehui Wang2Qingyuan Liu3Yaqi Wang4Ji Wang5National Institute of Traditional Chinese Medicine Constitution and Preventive Treatment of Diseases, Beijing University of Chinese MedicineCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese MedicineCentre for Evidence-Based Chinese Medicine, Beijing University of Chinese MedicineInstitute for TCM-X, Department of Automation, Tsinghua UniversityCollege of Basic Medical Sciences, Zhejiang Chinese Medical UniversityNational Institute of Traditional Chinese Medicine Constitution and Preventive Treatment of Diseases, Beijing University of Chinese MedicineAbstract Background Allergic Rhinitis (AR) is a prevalent chronic respiratory condition with limited long-term relief from Western medications. Interest in Traditional Chinese Patent Medicines (TCPMs) as a complementary approach is growing, but research on their efficacy and safety is lacking. We aim to evaluate the efficacy and safety of TCPMs listed in the 2020 Chinese Pharmacopoeia (ChP 2020) that are indicated for treating AR. Methods We will search PubMed, Embase, Web of Science, Cochrane Library, and four Chinese databases to retrieve randomized controlled trials investigating specific TCPMs (Biyankang tablets, Tongqiao Biyan Granules, Tongqiao Biyan Tablets, Tongqiao Biyan Capsules, Xinqin Granules, Xinqin Tablets, Xinyi Biyan Pills) for AR. Primary outcomes are Total Nasal Symptom Scores (TNSS) and Total Ocular Symptom Scores (TOSS). Secondary outcomes include quality of life, relapse rates, nasal function, biomarkers, and adverse events. No languages and publication data limitations. Meta-analysis will be performed using RevMan 5.4 with random effects model. Publication bias are set to be assessed using funnel plots and Egger’s test, and adjusted with the trim and fill method. Meta-regression will investigate factors influencing outcomes for AR. Study quality will be assessed using the Cochrane Risk of Bias 2.0 tool, and the Grading of Recommendations Assessment, Development, and Evaluation approach will be used to evaluate the quality of evidence. Discussion Despite the limitations of conventional AR medications, TCPMs show potential benefits in immune modulation and symptom relief. This review will focus on TCPMs listed in ChP 2020 to comprehensively evaluate their safety and efficacy for AR. Unlike existing reviews, this study emphasizes rigorous standards of TCPMs, aiming to provide a more reliable evidence base. Although a network meta-analysis would be ideal, a traditional meta-analysis will be conducted due to limited data. Future research should focus on direct comparative studies and utilize AI techniques for understanding mechanisms and enhancing personalized treatments. This review aims to bridge gaps in the current literature and potentially improve clinical guidelines and patient outcomes in AR management. Systematic review registration INPLASY202450121.https://doi.org/10.1186/s13643-024-02748-1Chinese patent medicines2020 Chinese PharmacopoeiaAllergic rhinitisProtocolSystematic reviewMeta-analysis
spellingShingle Weibo Zhao
Lingyao Kong
Xuehui Wang
Qingyuan Liu
Yaqi Wang
Ji Wang
Efficacy and safety of Chinese patent medicines for allergic rhinitis based on 2020 Chinese Pharmacopoeia: a protocol for systematic review and meta-analysis of randomized controlled trials
Systematic Reviews
Chinese patent medicines
2020 Chinese Pharmacopoeia
Allergic rhinitis
Protocol
Systematic review
Meta-analysis
title Efficacy and safety of Chinese patent medicines for allergic rhinitis based on 2020 Chinese Pharmacopoeia: a protocol for systematic review and meta-analysis of randomized controlled trials
title_full Efficacy and safety of Chinese patent medicines for allergic rhinitis based on 2020 Chinese Pharmacopoeia: a protocol for systematic review and meta-analysis of randomized controlled trials
title_fullStr Efficacy and safety of Chinese patent medicines for allergic rhinitis based on 2020 Chinese Pharmacopoeia: a protocol for systematic review and meta-analysis of randomized controlled trials
title_full_unstemmed Efficacy and safety of Chinese patent medicines for allergic rhinitis based on 2020 Chinese Pharmacopoeia: a protocol for systematic review and meta-analysis of randomized controlled trials
title_short Efficacy and safety of Chinese patent medicines for allergic rhinitis based on 2020 Chinese Pharmacopoeia: a protocol for systematic review and meta-analysis of randomized controlled trials
title_sort efficacy and safety of chinese patent medicines for allergic rhinitis based on 2020 chinese pharmacopoeia a protocol for systematic review and meta analysis of randomized controlled trials
topic Chinese patent medicines
2020 Chinese Pharmacopoeia
Allergic rhinitis
Protocol
Systematic review
Meta-analysis
url https://doi.org/10.1186/s13643-024-02748-1
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