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.

 

Available Downloads

The main CONSORT flow diagram should be used.

Document Word Format PDF Format
Statement Document n/a Download
Checklist n/a n/a
Explanation & Elaboration n/a Download

References

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.
PMID: 16781628

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

Extensions of the CONSORT Statement

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.

 

Finding the Appropriate Extension

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.

 

Designs
Interventions
Data
Cluster Trials Herbal Medicinal Interventions CONSORT-PRO
Non-Inferiority and Equivalence Trials Non-Pharmacologic Treatment Interventions Harms
Pragmatic Trials Acupuncture Interventions

Abstracts

N-of-1 Trials Chinese Herbal Medicine Formulas  
Pilot and Feasibility Trials     
Within Person Trials