Clinical research report on Chinese patent medicines and classic traditional Chinese medicine prescriptions (2023)

Objective: Randomized controlled trials (RCTs) of Chinese patent medicines and classic traditional Chinese medicine prescriptions were systematically reviewed from both Chinese and English journals published in 2023. A preliminary summary and evaluation were conducted on the generation and translati...

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Main Authors: Xiaolei Wu, Haiyin Hu, Yuetong Wang, Alice Josephine Fauci, Yazi Zhang, Wenting Song, Fengwen Yang, Boli Zhang, Junhua Zhang, Zhaochen Ji
Format: Article
Language:English
Published: KeAi Communications Co., Ltd. 2025-06-01
Series:Digital Chinese Medicine
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Online Access:http://www.sciencedirect.com/science/article/pii/S2589377725000746
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author Xiaolei Wu
Haiyin Hu
Yuetong Wang
Alice Josephine Fauci
Yazi Zhang
Wenting Song
Fengwen Yang
Boli Zhang
Junhua Zhang
Zhaochen Ji
author_facet Xiaolei Wu
Haiyin Hu
Yuetong Wang
Alice Josephine Fauci
Yazi Zhang
Wenting Song
Fengwen Yang
Boli Zhang
Junhua Zhang
Zhaochen Ji
author_sort Xiaolei Wu
collection DOAJ
description Objective: Randomized controlled trials (RCTs) of Chinese patent medicines and classic traditional Chinese medicine prescriptions were systematically reviewed from both Chinese and English journals published in 2023. A preliminary summary and evaluation were conducted on the generation and translation of clinical evidence for these treatments. This analysis aims to inform future research on clinical efficacy evaluation and guide the rational application of evidence. Methods: RCTs of Chinese patent medicines and classic traditional Chinese prescriptions published in 2023 were comprehensively retrieved from the Artificial Intelligence Clinical Evidence Database for Chinese Patent Medicine (AICED-CPM), with supplementary searches conducted in China National Knowledge Infrastructure (CNKI), Wanfang Data, Chinese Science and Technology Journal Database (VIP), Chinese Biomedical Literature Database (SinoMed), Cochrane Library, PubMed, Embase, and Web of Science. The study characteristics and methodological quality of these RCTs were systematically analyzed and evaluated. Results: A total of 1 443 RCTs of Chinese patent medicines were included, comprising 1 399 Chinese articles and 44 English articles. Additionally, 334 RCTs of classic traditional Chinese medicine prescriptions were found, with 331 published in Chinese and 3 in English. 196 567 participants were included, covering 585 types of Chinese patent medicines (487 oral, 61 injectable, and 37 topical) and 179 classic traditional Chinese medicine prescriptions. The involved studies encompassed 22 types of diseases, with research primarily focusing on diseases of the circulatory system, the respiratory system, and the genitourinary system. The sample sizes ranged from 18 to 3 777 participants, and most studies were conducted at a single center. Methodologically, the implementation of allocation concealment and blinding remained insufficiently emphasized. Conclusion: Overall, compared with 2022, both the number of RCT publications and their methodological quality have improved in 2023, with heightened attention to research on diseases of the genitourinary system. However, quality control and standardized management in the design and implementation processes still require enhancement to produce more high-quality clinical evidence and accelerate the translation and application of this evidence.
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series Digital Chinese Medicine
spelling doaj-art-55c8a632e28f45de91d637b82d0b9c1e2025-08-20T03:32:58ZengKeAi Communications Co., Ltd.Digital Chinese Medicine2589-37772025-06-018212313610.1016/j.dcmed.2025.06.001Clinical research report on Chinese patent medicines and classic traditional Chinese medicine prescriptions (2023)Xiaolei Wu0Haiyin Hu1Yuetong Wang2Alice Josephine Fauci3Yazi Zhang4Wenting Song5Fengwen Yang6Boli Zhang7Junhua Zhang8Zhaochen Ji9Center for Evidence-based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, ChinaHaihe Laboratory of Modern Chinese Medicine, Tianjin 301617, ChinaCenter for Evidence-based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, ChinaJoint Sino-Italian Laboratory of Traditional Chinese Medicine, Italian National Institute of Health, Lazio, Rome 00161, ItalyCenter for Evidence-based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, ChinaCenter for Evidence-based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, ChinaCenter for Evidence-based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, ChinaCenter for Evidence-based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China; Haihe Laboratory of Modern Chinese Medicine, Tianjin 301617, China; State Key Laboratory of Component-based Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China; Corresponding author.Center for Evidence-based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China; Haihe Laboratory of Modern Chinese Medicine, Tianjin 301617, China; Corresponding author.Center for Evidence-based Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China; Haihe Laboratory of Modern Chinese Medicine, Tianjin 301617, China; Joint Sino-Italian Laboratory of Traditional Chinese Medicine, Italian National Institute of Health, Lazio, Rome 00161, Italy; Corresponding author.Objective: Randomized controlled trials (RCTs) of Chinese patent medicines and classic traditional Chinese medicine prescriptions were systematically reviewed from both Chinese and English journals published in 2023. A preliminary summary and evaluation were conducted on the generation and translation of clinical evidence for these treatments. This analysis aims to inform future research on clinical efficacy evaluation and guide the rational application of evidence. Methods: RCTs of Chinese patent medicines and classic traditional Chinese prescriptions published in 2023 were comprehensively retrieved from the Artificial Intelligence Clinical Evidence Database for Chinese Patent Medicine (AICED-CPM), with supplementary searches conducted in China National Knowledge Infrastructure (CNKI), Wanfang Data, Chinese Science and Technology Journal Database (VIP), Chinese Biomedical Literature Database (SinoMed), Cochrane Library, PubMed, Embase, and Web of Science. The study characteristics and methodological quality of these RCTs were systematically analyzed and evaluated. Results: A total of 1 443 RCTs of Chinese patent medicines were included, comprising 1 399 Chinese articles and 44 English articles. Additionally, 334 RCTs of classic traditional Chinese medicine prescriptions were found, with 331 published in Chinese and 3 in English. 196 567 participants were included, covering 585 types of Chinese patent medicines (487 oral, 61 injectable, and 37 topical) and 179 classic traditional Chinese medicine prescriptions. The involved studies encompassed 22 types of diseases, with research primarily focusing on diseases of the circulatory system, the respiratory system, and the genitourinary system. The sample sizes ranged from 18 to 3 777 participants, and most studies were conducted at a single center. Methodologically, the implementation of allocation concealment and blinding remained insufficiently emphasized. Conclusion: Overall, compared with 2022, both the number of RCT publications and their methodological quality have improved in 2023, with heightened attention to research on diseases of the genitourinary system. However, quality control and standardized management in the design and implementation processes still require enhancement to produce more high-quality clinical evidence and accelerate the translation and application of this evidence.http://www.sciencedirect.com/science/article/pii/S2589377725000746Traditional Chinese medicineChinese patent medicineClassic traditional Chinese medicine prescriptionsRandomized controlled trials (RCTs)Evidence-based medicine
spellingShingle Xiaolei Wu
Haiyin Hu
Yuetong Wang
Alice Josephine Fauci
Yazi Zhang
Wenting Song
Fengwen Yang
Boli Zhang
Junhua Zhang
Zhaochen Ji
Clinical research report on Chinese patent medicines and classic traditional Chinese medicine prescriptions (2023)
Digital Chinese Medicine
Traditional Chinese medicine
Chinese patent medicine
Classic traditional Chinese medicine prescriptions
Randomized controlled trials (RCTs)
Evidence-based medicine
title Clinical research report on Chinese patent medicines and classic traditional Chinese medicine prescriptions (2023)
title_full Clinical research report on Chinese patent medicines and classic traditional Chinese medicine prescriptions (2023)
title_fullStr Clinical research report on Chinese patent medicines and classic traditional Chinese medicine prescriptions (2023)
title_full_unstemmed Clinical research report on Chinese patent medicines and classic traditional Chinese medicine prescriptions (2023)
title_short Clinical research report on Chinese patent medicines and classic traditional Chinese medicine prescriptions (2023)
title_sort clinical research report on chinese patent medicines and classic traditional chinese medicine prescriptions 2023
topic Traditional Chinese medicine
Chinese patent medicine
Classic traditional Chinese medicine prescriptions
Randomized controlled trials (RCTs)
Evidence-based medicine
url http://www.sciencedirect.com/science/article/pii/S2589377725000746
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