Herbal Medicinal Interventions
A CONSORT extension for reporting herbal medicines was published in 2006, elaborating on 9 items of the CONSORT (2001) checklist; it can be downloaded below.
Given that herbal medicinal products are widely used, vary greatly in content and quality, and are actively tested using randomized controlled trials (RCTs), recommendations were developed to improve reporting RCTs of herbal medicine interventions.
The main CONSORT flow diagram should be used.
Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C. Reporting randomized, controlled trials of herbal interventions: an elaborated CONSORT statement. Ann Intern Med 2006; 144(5):364-367. PMID: 16520478
Gagnier J, Boon H, Rochon P, Barnes J, Moher D, Bombardier C. Improving the quality of reporting of randomized controlled trials evaluating herbal interventions: implementing the CONSORT statement [corrected]. Explore (NY) 2006; 2(2):143-149.
Gagnier JJ, Boon H, Rochon P, Moher D, Barnes J, Bombardier C. Recommendations for reporting randomized controlled trials of herbal interventions: explanation and elaboration. J Clin Epidemiol 2006; 59(11):1134-1149. PMID: 17027423
The main CONSORT Statement is based on the "standard" two-group parallel design. However, there are several variations to the standard trial methodology, including different design aspects (e.g., cluster), interventions (e.g., herbals) and data (e.g., harms).
To help improve the reporting of these trials the main CONSORT Statement has been extended and modified by members of the CONSORT group for application in these various areas. The resulting CONSORT extensions are presented in this section. This list is, by no means, exhaustive; and work is constantly in progress.
Please note that modifications to the CONSORT checklist or flow diagram that are not developed with the involvement of the CONSORT Group do not have permission to name their work "CONSORT".
Some work, however, has been done to modify the CONSORT Statement without the involvement of the Group. These unofficial extensions of the CONSORT Statement can be found here.
The table below lists the current official extensions of the CONSORT statement. You can click on each extension to learn more about it or to explore that extension in the checklist viewer application.
|Cluster Trials||Herbal Medicinal Interventions||CONSORT-Outcomes 2022 Checklist (for combined completion of CONSORT 2010)||CONSORT-PRO|
|Non-Inferiority and Equivalence Trials||Non-Pharmacologic Treatment Interventions||CONSORT-Outcomes 2022 Extension items only (for separate completion of CONSORT 2010 and CONSORT-Outcomes 2022 items)||Harms|
|Pragmatic Trials||Acupuncture Interventions|
|N-of-1 Trials||Chinese Herbal Medicine Formulas||Equity|
|Pilot and Feasibility Trials||Social and Psychological Interventions||Randomised Crossover Trial Reporting|
|Within Person Trials|
|Multi-Arm Parallel-Group Randomized Trials|