Ensayos Clínicos Aleatorizados Controlados

Journal of Clinical Epidemiology 59 (2006) 1134e1149

Recommendations for reporting randomized controlled trials
of herbal interventions: explanation and elaboration
Joel J. Gagniera,b,*, Heather Boonc, Paula Rochona,c, David Moherd,e,f,
Joanne Barnesg, Claire Bombardiera,h, for the CONSORT Group1
a

Department of Health Policy, Management and Evaluation, Faculty of Medicine, Universityof Toronto, Toronto, Ontario, Canada
b
Canadian College of Naturopathic Medicine, Toronto, Ontario, Canada
c
Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada
d
Children’s Hospital of Eastern Ontario Research Institute, Ottawa, Canada
e
Department of Pediatrics, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada
f
Department of Epidemiology & CommunityMedicine, Faculty of Medicine, University of Ottawa, Ottawa, Ontario, Canada
g
Centre for Pharmacognosy & Phytotherapy, School of Pharmacy, University of London, London, United Kingdom
h
Institute for Work & Health, Toronto, Ontario, Canada
Accepted 16 December 2005

Abstract
Controlled trials that use randomized allocation are the best tool to control for bias and confounding in trialstesting clinical interventions. Investigators must be sure to include information that is required by the reader to judge the validity and implications of the findings in
the reports of these trials. In part, complete reporting of trials will allow clinicians to modify their clinical practice to reflect current evidence toward the improvement of clinical outcomes. The consolidated standards ofreporting trials (CONSORT) statement was developed
to assist investigators, authors, reviewers, and editors on the necessary information to be included in reports of controlled clinical trials. The
CONSORT statement is applicable to any intervention, including herbal medicinal products. Controlled trials of herbal interventions do not
adequately report the information suggested in CONSORT. Recently,reporting recommendations were developed in which several CONSORT items were elaborated to become relevant and complete for randomized controlled trials of herbal medicines. We expect that these
recommendations will lead to more complete and accurate reporting of herbal trials. We wrote this explanatory document to outline the
rationale for each recommendation and to assist authors in using themby providing the CONSORT items and the associated elaboration,
together with examples of good reporting and empirical evidence, where available, for each. These recommendations for the reporting of
herbal medicinal products presented here are open to revision as more evidence accumulates and critical comments are collected. Ó 2006
Elsevier Inc. All rights reserved.
Keywords: Reportingrecommendations; CONSORT statement; Herbal medicines; Randomized controlled trials; Consensus technique

1. Introduction
Randomized controlled trials (RCTs) provide the best
evidence for efficacy of healthcare interventions [1].
Carefully planned and well-executed RCTs give us the best
estimates of treatment effect and can thus guide clinical
decision making [2,3], although trials that lackmethodological rigor cause over- or underestimation of treatment effect sizes due to bias or confounding factors [4e9]. Hence,

1
Members of this group are listed in Section 8.
* Corresponding author. 5955 Ontario Street, Unit #307, Windsor, Ontario, Canada, N8S1W6. Tel.: þ1-519-974-9690; fax: þ1-519-258-2396.
E-mail address: j.gagnier@utoronto.ca (J.J. Gagnier).

0895-4356/06/$ e see front matterÓ 2006 Elsevier Inc. All rights reserved.
doi: 10.1016/j.jclinepi.2005.12.020

efforts have been undertaken toward improving the design
and reporting of RCTs [1,6,10,11].
Current research suggests that reporting quality of complementary and alternative medicine (CAM) trials is poor
[12,13]. Linde et al. [12,14] found that most CAM trials
do not describe the generation of the random...