Reporting guidelines of Chinese medicine: Current situation and future development

Zhang, Xuan; Chung, Wai Chak Andrew; Lau, Chung Tai; Wang, Nana

doi:10.1016/j.jtcms.2022.06.008

Cited by 4 publications

(6 citation statements)

References 41 publications

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“… 72 Over the past decade, a system of reporting guidelines for TCM clinical trials has been established, addressing various TCM interventions. 73 Guidelines have been developed on trial registration, protocol design, results publication, evidence synthesis and clinical practice, yet their application remains suboptimal. 73 It is necessary to explore the possible reasons for the overall low concordance to improve the quality of trials in acupuncture, CHM, and TCQ in cancer care.…”

Section: Discussionmentioning

confidence: 99%

“… 73 Guidelines have been developed on trial registration, protocol design, results publication, evidence synthesis and clinical practice, yet their application remains suboptimal. 73 It is necessary to explore the possible reasons for the overall low concordance to improve the quality of trials in acupuncture, CHM, and TCQ in cancer care. The common reasons are as below.…”

Section: Discussionmentioning

confidence: 99%

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Are Published Cancer Care Trial Protocols With Traditional Chinese Medicine Interventions Concordant With SPIRIT-TCM Extension 2018? A Scoping Review on Published Trial Protocols Between 2019 and 2022

Lai,

Yang,

Wang

et al. 2024

Integr Cancer Ther

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Background: The SPIRIT-TCM Extension 2018 was created to guide the design and reporting of Traditional Chinese Medicine (TCM) clinical trial protocols. This study aims to investigate the extent of concordance with this guideline in the relevant field of cancer care research. Methods: A scoping review of TCM cancer trial protocols published in English and Chinese since January 2019 was conducted. Five major academic databases (MEDLINE, EMBASE, CINAHL, CENTRAL, and China National Knowledge Infrastructure) were searched. Concordance with the SPIRIT-TCM Extension 2018 was assessed by descriptive analysis. Results: Fifty-three TCM cancer care trial protocols were identified, comprising 23 acupuncture, 26 Chinese herbal medicine (CHM), and 4 Tai Chi/Qigong (TCQ) interventions. The majority of the checklist items had a low rate of concordance, especially in the reporting of quality control and safety, dosage, TCM diagnostic patterns, possible interactions between Western Medicine and TCM interventions, and TCM-related outcome assessments. Conclusions: Although the SPIRIT-TCM Extension 2018 guideline was established through extensive Delphi consultation, there are low rates of concordance between published TCM cancer care clinical trial protocols with the guideline. Further research is necessary to understand the low rate of concordance and how scientific rigors of reporting can be improved in TCM cancer care research.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Are Published Cancer Care Trial Protocols With Traditional Chinese Medicine Interventions Concordant With SPIRIT-TCM Extension 2018? A Scoping Review on Published Trial Protocols Between 2019 and 2022

Lai,

Yang,

Wang

et al. 2024

Integr Cancer Ther

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“…Simultaneously, we will prepare the translations (e.g., Chinese version) of the guideline according to the CONSORT translation policy. Third, we seek relevant journals to endorse the STRICTOTM and, if applicable, suggest Chinese journals of TCM to take measures to improve author adherence to these recommendations 84 …”

Section: Discussionmentioning

confidence: 99%

“…Third, we seek relevant journals to endorse the STRICTOTM and, if applicable, suggest Chinese journals of TCM to take measures to improve author adherence to these recommendations. 84…”

Section: Disseminationmentioning

confidence: 99%

STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM): Extending the CONSORT statement

Zhang

Liang

Lau

et al. 2023

J Evidence Based Medicine

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Objectives Massage is a common therapy of nonpharmacological treatments, particularly in Tuina (Chinese massage) as its most common style, detailed guidance in reporting the intervention is warranted for its evaluation and replication. Based on the CONSORT (Consolidated Standards of Reporting Trials), we aimed to develop an Extension for Tuina/Massage, namely “The STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM).” Methods A group of professional clinicians, trialists, methodologists, developers of reporting guidelines, epidemiologists, statisticians, and editors has developed this STRICTOTM checklist through a standard methodology process recommended by the EQUATOR (Enhancing the QUAlity and Transparency of Health Research) Network, including prospective registration, literature review, draft of the initial items, three rounds of the Delphi survey, consensus meeting, pilot test, and finalization of the guideline. Results A checklist of seven items (namely Tuina/Massage rationale, details of Tuina/Massage, intervention regimen, other components of the intervention, Tuina/Massage provider background, control or comparator interventions, and precaution measures), and 16 subitems were developed. Explanations and examples (E&E) for each item are also provided. Conclusions The working group hopes that the STRICTOTM, in conjunction with both the CONSORT statement and extension for nonpharmacologic treatment, can improve the reporting quality and transparency of Tuina/Massage clinical research.

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“…Additionally, there is a scarcity of systematic studies addressing this issue. Previous research has highlighted the inadequate utilization and endorsement of the CONSORT extensions for TCM reporting guidelines ( Zhang et al, 2022 ). To bridge this gap, our objective is to scrutinize a selection of TCM RCT protocols from the past 3 years, with a particular focus on CHMF, acupuncture, and moxibustion—areas covered by the SPIRIT-TCM Extension 2018 guideline.…”

Section: Introductionmentioning

confidence: 99%

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

Zhang,

Li,

et al. 2024

Front. Pharmacol.

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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.

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Reporting guidelines of Chinese medicine: Current situation and future development

Cited by 4 publications

References 41 publications

Are Published Cancer Care Trial Protocols With Traditional Chinese Medicine Interventions Concordant With SPIRIT-TCM Extension 2018? A Scoping Review on Published Trial Protocols Between 2019 and 2022

Are Published Cancer Care Trial Protocols With Traditional Chinese Medicine Interventions Concordant With SPIRIT-TCM Extension 2018? A Scoping Review on Published Trial Protocols Between 2019 and 2022

STandards for Reporting Interventions in Clinical Trials Of Tuina/Massage (STRICTOTM): Extending the CONSORT statement

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

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