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

Lin Zhang, Han Li, Lihan Hu, Xiangqin Ou, Hanzhi Tan, Xuanqi Zhang, Chung Tai Lau, Aiping Lu, Zhaoxiang Bian, Xuan Zhang*

*Corresponding author for this work

Research output: Contribution to journalJournal articlepeer-review

Abstract

Objectives: The 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.

Methods: We 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.

Results: Of 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.

Conclusion: Continued, 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.
Original languageEnglish
Article number1389808
Number of pages16
JournalFrontiers in Pharmacology
Volume15
DOIs
Publication statusPublished - 7 Jun 2024

Scopus Subject Areas

  • Pharmacology (medical)
  • Pharmacology

User-Defined Keywords

  • SPIRIT guideline
  • evidence synthesis
  • open science framework
  • randomized controlled trial
  • reporting quality
  • traditional Chinese medicine registration
  • traditional Chinese medicine registration: open science framework

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