Reporting randomized, controlled trials of herbal interventions: An elaborated CONSORT statement

University of Toronto, Institute for Evaluative Sciences, Toronto, Canada.
Annals of internal medicine (Impact Factor: 17.81). 04/2006; 144(5):364-7.
Source: PubMed


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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    • "lz et al . , 2010 ) . Additionally there have been multiple extensions to address specific types of trial designs , for example parallel group designs ( Moher et al . , 2001 ) , or non - inferiority and equivalence trials ( Piaggio et al . , 2006 ) or interventions , for example non - pharmacologic treatments ( Boutron et al . , 2008 ) , herbals ( Gagnier et al . , 2006 ) or acu - puncture ( MacPherson et al . , 2010 ) . Other groups in obstetrics and gyne - cology have modified the CONSORT checklist for obstetric trials ( Chauhan et al . , 2013 ) ."
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    • "Assessment of risk of bias was performed independently by two reviewers (YB and SHJ), with disagreements resolved by discussion. Risk of bias was assessed according to the elaborated CONSORT checklist for herbal interventions (Gagnier et al., 2006, 2006) by recording characteristics of the herbal product, qualitative testing, dosage regimen and quantitative description, method used to generate the randomization schedule and conceal allocation, whether blinding was implemented, what proportion of patients completed follow-up, and whether an intention-to-treat analysis was extractable etc.. 2-properly with detailed description, 1-mentioned but not detailed reported, 0-not mentioned or inappropriate. A trial with a quality score ≤ 18 was considered as a trial at high risk of bias, and a trial with a quality score ≥ 36 was considered as a trial at low risk of bias, the left were at moderate risk of bias. "
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    • "There are extensions to CONSORT for the reporting of interventions such as herbal and homeopathic interventions [92,93], non-pharmacological treatments [94], acupuncture [95], E-Health [96] and tailored interventions [97]. The collaborators of the CONSORT group have recently developed the TIDIER checklist and guide [27], a generic reporting guideline for interventions, irrespective of the type of intervention, where no other specific guidance exists. "
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