Reporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement
Abstract
Herbal medicinal products are widely used, vary greatly in content and quality, and are actively tested in randomized, controlled trials (RCTs). The authors' objective was to develop recommendations for reporting RCTs of herbal medicine interventions, based on the need to elaborate on the 22-item CONSORT (Consolidated Standards of Reporting Trials) checklist. Telephone calls were made and a consensus meeting was held with 16 participants in Toronto, Canada, to develop these recommendations. The group agreed on context-specific elaborations of 9 CONSORT checklist items for RCTs of herbal medicines. Item 4, concerning the herbal medicine intervention, required the most extensive elaboration. These recommendations have been developed to improve the reporting of RCTs using herbal medicine interventions.
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A small number of CONSORT extension statements contain expanded guidance about describing interventions, such as non-pharmacological interventions and specific intervention categories, such as acupuncture and herbal interventions.
“A small number of CONSORT extension statements contain expanded guidance about describing interventions, such as non-pharmacological interventions 6 and specific intervention categories, such as acupuncture and herbal interventions. 7,8”
From Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide (2014) · cites this paper as [8]
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Untitled work
von Elm, E., Altman, D. G., Egger, M., Pocock, S. J., Gøtzsche, P. C., & Vandenbroucke, J. P. (2007) · PLoS Medicine
- Authors
- Gagnier, J. J., Boon, H., Rochon, P., Moher, D., Barnes, J., Bombardier, C., & for the CONSORT Group*
- Affiliations
- University of London (GB)
- Venue
- Annals of Internal Medicine
- Publisher
- American College of Physicians
- Published
- 2006-03-07
- Volume
- 144
- Issue
- 5
- Pages
- 364-367
- ISSN
- 0003-4819 (ISSN-L)
- 1539-3704
- OpenAlex
- W2108432873
- Cited by
- 608
- References
- 2
- Citations by year
- 2026: 38 · 2025: 26 · 2024: 27 · 2023: 17 · 2022: 27 · 2021: 19 · 2020: 31 · 2019: 31 · 2018: 27 · 2017: 22 · 2016: 26 · 2015: 40 · 2014: 35 · 2013: 34 · 2012: 25
- FWCI
- 41.51
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Annals of Internal Medicine (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Keywords
- herbal medicine, randomized controlled trials, trial reporting, CONSORT checklist, reporting guidelines, herbal intervention, herbal medicinal products, consensus recommendations
- MeSH terms
- Publishing, Research Design, Randomized Controlled Trials as Topic, Herbal Medicine
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