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.

Download full-text


Available from: Heather Boon
    • "and rigorous characterization of DS products are needed to ensure the presence of expected ingredients and to detect any contaminants or adulterants. The NCCIH established policies to promote thorough characterization in all DS research they support[18]in the wake of high-profile cases of product adulteration,[19,20]but such stringent and appropriately comprehensive product analysis is also critical for reproducibility in studies of both biological mechanisms and health outcomes.2122232425Validated methods for the analysis of natural products are therefore critically important not only for DS manufacturers and regulators, but also researchers.[26]Since "
    [Show abstract] [Hide abstract]
    ABSTRACT: Mechanistic, clinical, and epidemiological research relevant to dietary supplements (DS) is supported by the U.S. National Institutes of Health. The Office of Dietary Supplements and the National Center for Complementary and Integrative Health promote the development and appropriate use of rigorous and comprehensive DS analyses which are critical for research reproducibility, particularly when the investigational DS include chemically complex natural products with unclear mechanisms of action.
    No preview · Article · Jan 2016 · Drug Testing and Analysis
  • Source
    • "This protocol was developed according to the guidelines for randomized controlled trials investigating Chinese herbal medicine[14]and follows the nine CONSORT checklist items for RCTs of herbal medicines[15]. We considered the main elements for conducting a high-quality RCT, such as randomization, sequence generation , allocation concealment, blinding methods, proper sample size, compliance with the protocol, and adequate outcome measures[15]. This research will provide important evidence regarding the more widespread use of CBT for the treatment of acne vulgaris. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Background: Due to increasing interest from acne patients concerned about the side effects associated with conventional therapies, complementary and alternative medicine (CAM) has been suggested as a new therapeutic modality for acne vulgaris. Herbal medicine is one of these CAM treatments. Cheongsangbangpoong-tang (CBT) is a common herbal formula used in patients with acne vulgaris in the clinical practice of Korean Medicine (KM). However, despite the common use of CBT in clinical practice, the current level of evidence is insufficient to support an inhibitory effect of CBT on inflammatory acne lesions and facial heat. Therefore, this study was designed to assess the inhibitory effect of CBT on both inflammatory acne lesions and facial heat. Methods/design: A randomized, double-blind, parallel-group, and placebo-controlled trial will be conducted. Fifty-six participants with acne vulgaris will be randomized into one of two groups: the CBT or placebo groups. After randomization, participants will be prescribed either CBT or placebo three times a day at a dose of 5 g after meals for 8 weeks. The following outcome measurements will be used in the examination of subjects: the mean percentage change and the count change of the inflammatory and non-inflammatory acne lesions, the temperature of facial points on digital infrared thermal imaging (DITI), serum cortisol, serum dehydroepiandrosterone-sulfate (DHEA-S), visual analogue scale (VAS), investigator global assessment (IGA), and severity score on the Korean Acne Grading System (KAGS) from baseline to the end of the trial. Discussion: This trial will provide evidence regarding the inhibitory effect of CBT on inflammatory acne lesions and facial heat. The findings of this trial may have important implications for the more widespread use of CBT for the treatment of acne vulgaris. Trial registration: The trial is registered with the Clinical Research Information Service (CRiS), Republic of Korea: KCT0001468 .
    Preview · Article · Dec 2015 · BMC Complementary and Alternative Medicine
  • Source
    • "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 ) ."
    [Show abstract] [Hide abstract]
    ABSTRACT: Infertility is a common disability, and is listed by theWorld Health Organization as the fifth leading serious disability among populations under the age of 60 years. Effective therapies exist, but evidence-based options are uncommon. Clinical trials in infertility treatment lack uniform guidelines for reporting methodology and results. Clinical trials in infertility are unique in that they usually involve, at minimum, two individuals who may receive or participate in treatment, i.e. a woman and a man, and if treatment is successful, a third individual is followed in the trial, i.e. an infant, who is also the desired outcome of the treatment. This tri-partite involvement of three unique humans in a clinical trial is unprecedented in other clinical trials and the CONSORT (Consolidated Standards Of Reporting Trials) guidelines leave several areas of uncertainty in what to report with multiple individuals involved. Two of the individuals, a woman seeking pregnancy and the infant, have been classified ethically as vulnerable populations requiring careful collection of all adverse events, including congenital anomaly rates. Participants may experience varied risk and benefit from the trial, for example multiple pregnancy may be desired by the father, feared by the mother, and fatal to the infant. The outcome of primary interest to participants, i.e. a live birth, is separated fromthe actual treatment by 9 months and subject to confounding influences from other factors. These myriad issues lead to incomplete and inconsistent reporting of results.We developed this modification to the CONSORT statement, which we describe and justify in this document, in order to report the items of vital interest to infertile couples, clinicians and the public that should be collected in an infertility trial.
    Full-text · Article · Oct 2014 · Human Reproduction
Show more