Reporting characteristics and quality of randomized controlled trial protocols in traditional Chinese medicine: a cross-sectional study

ObjectivesThe impact of the Standard Protocol Items: Recommendations for Interventional Trials of Traditional Chinese Medicine (SPIRIT-TCM) Extension 2018 statement on the reporting quality of randomized controlled trial (RCT) protocols in traditional Chinese medicine (TCM) is not clear. This review...

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Main Authors: Lin Zhang (Author), Han Li (Author), Lihan Hu (Author), Xiangqin Ou (Author), Hanzhi Tan (Author), Xuanqi Zhang (Author), Chung Tai Lau (Author), Aiping Lyu (Author), Zhaoxiang Bian (Author), Xuan Zhang (Author)
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Published: Frontiers Media S.A., 2024-06-01T00:00:00Z.
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100 1 0 |a Lin Zhang  |e author 
700 1 0 |a Han Li  |e author 
700 1 0 |a Lihan Hu  |e author 
700 1 0 |a Xiangqin Ou  |e author 
700 1 0 |a Hanzhi Tan  |e author 
700 1 0 |a Xuanqi Zhang  |e author 
700 1 0 |a Chung Tai Lau  |e author 
700 1 0 |a Aiping Lyu  |e author 
700 1 0 |a Aiping Lyu  |e author 
700 1 0 |a Zhaoxiang Bian  |e author 
700 1 0 |a Zhaoxiang Bian  |e author 
700 1 0 |a Zhaoxiang Bian  |e author 
700 1 0 |a Zhaoxiang Bian  |e author 
700 1 0 |a Xuan Zhang  |e author 
700 1 0 |a Xuan Zhang  |e author 
700 1 0 |a Xuan Zhang  |e author 
700 1 0 |a Xuan Zhang  |e author 
245 0 0 |a Reporting characteristics and quality of randomized controlled trial protocols in traditional Chinese medicine: a cross-sectional study 
260 |b Frontiers Media S.A.,   |c 2024-06-01T00:00:00Z. 
500 |a 1663-9812 
500 |a 10.3389/fphar.2024.1389808 
520 |a ObjectivesThe impact of the Standard Protocol Items: Recommendations for Interventional Trials of Traditional Chinese Medicine (SPIRIT-TCM) Extension 2018 statement on the reporting quality of randomized controlled trial (RCT) protocols in traditional Chinese medicine (TCM) is not clear. This review aimed to assess the reporting characteristics and quality of RCT protocols involving interventions such as Chinese herbal medicine formulas (CHMF), acupuncture, and moxibustion published in the last 3 years.MethodsWe conducted an extensive search among multiple databases, including All EBM Reviews, Allied and Complementary Medicine (AMED), Embase, Ovid MEDLINE(R), PubMed, Web of Science, Google Scholar, and ClinicalTrials.gov for publications in English from 1 January 2020 to 10 August 2023. Two reviewers independently assessed the eligibility of the publications, extracted predetermined information, and evaluated the reporting based on the SPIRIT-TCM Extension 2018 checklist.ResultsOf the 420 eligible protocols (comprising 163 studies on CHMF, 239 on acupuncture, and 18 on moxibustion), the average reporting compliance rate was only 35.4%. Approximately half of the assessed items fell into the category of poorly reported, demonstrating a compliance rate below 65%. Notably, reporting compliance in acupuncture and moxibustion interventional studies exhibited higher scores than compliance in CHMF studies.ConclusionContinued, concerted, and coordinated efforts are required by journals, editors, reviewers, and investigators to improve the application and promotion of the SPIRIT-TCM Extension 2018 reporting guideline. 
546 |a EN 
690 |a evidence synthesis 
690 |a randomized controlled trial 
690 |a reporting quality 
690 |a SPIRIT guideline 
690 |a traditional Chinese medicine registration: open science framework 
690 |a Therapeutics. Pharmacology 
690 |a RM1-950 
655 7 |a article  |2 local 
786 0 |n Frontiers in Pharmacology, Vol 15 (2024) 
787 0 |n https://www.frontiersin.org/articles/10.3389/fphar.2024.1389808/full 
787 0 |n https://doaj.org/toc/1663-9812 
856 4 1 |u https://doaj.org/article/c2b8971e34c44b4eb14f3a30f53cb038  |z Connect to this object online.