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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Available from: Heather Boon, Oct 07, 2015
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    • "We developed these changes in three phases, including a pre-meeting planning phase, the meeting itself and a post meeting review of results based on previous extensions to the CONSORT checklist (Gagnier et al., 2006; Boutron et al., 2008; MacPherson et al., 2010), and published guidance for implementing such change (Moher et al., 2010). In planning for the meeting, we sought to assemble a representative group of experienced investigators in trials of infertility treatments as well as the editors of the leading journals that publish fertility trials, Fertility & Sterility and Human Reproduction, to participate in the meeting. "
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    ABSTRACT: Clinical trials testing infertility treatments often do not report on the major outcomes of interest to patients and clinicians and the public (such as live birth) nor on the harms, including maternal risks during pregnancy and fetal anomalies. This is complicated by the multiple participants in infertility trials which may include a woman (mother), a man (father), and result in a third individual if successful, their offspring (child), whois also the desired outcome of treatment. The primary outcome of interest and manyadverse events occur after cessation of infertility treatment and during pregnancy and the puerperium, which create a unique burden of follow-up for clinical trial investigators and participants. In 2013, because of the inconsistencies in trial reporting and the unique aspects of infertility trials not adequately addressed by existingConsolidated Standards of Reporting Trials (CONSORT) statements, we convened a consensus conference in Harbin, China, with the aim of planning modifications to theCONSORTchecklist to improve the quality of reporting of clinical trials testing infertility treatment. The consensus group recommended that the preferred primary outcome of all infertility trials is live birth (defined as any delivery of a live infant ≥20 weeks gestations) or cumulative live birth, defined as the live birth per women over a defined time period (or number of treatment cycles). In addition, harms to all participants should be systematically collected and reported, including during the intervention, any resulting pregnancy, and during the neonatal period. Routine information should be collected and reported on both male and female participants in the trial.We propose to track the change in quality that these guidelines may produce in published trials testing infertility treatments. Our ultimate goal is to increase the transparency of benefits and risks of infertility treatments to provide better medical care to affected individuals and couples.
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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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    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.
    Human Reproduction 10/2014; · 4.57 Impact Factor
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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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    ABSTRACT: Background: This study was aimed at determining the effects and safety of Da-Cheng-Qi decoction (DCQD) or DCQD combined with conservative therapy in patients with intestinal obstruction. Materials and methods: PubMed, EMBASE, Cochrane Controlled Trials Register, and several other databases were searched. Randomised controlled trials (RCTs) of DCQD or DCQD plus conservative therapy in patients with intestinal obstruction were eligible. Therapeutic effect was estimated by the improvement of clinical manifestations and diagnostic imaging; dichotomous/ordinal data assessment of overall response to therapy, adverse effects; or continuous variable were identified, including time to first bowel movement, time to first flatus, length of hospital stay. Results: Sixty eligible RCTs including 6,095 patients were identified. Response rate: (1) DCQD versus conservative therapy (6 RCTs, 361 patients, RR of respond =1.13; 95% CI 0.97 to 1.31). (2) DCQD plus conservative therapy versus conservative therapy (48 RCTs, 4,916 patients, RR of respond =1.25 which favoured DCQD plus conservative therapy; 95% CI 1.20 to 1.30). Treatment effect remained similar when RCTs at high risk of bias were excluded. Time to first flatus postoperatively: (1) DCQD versus conservative therapy (2 RCTs, 240 patients, SMD=-3.65; 95% CI -8.17 to 0.87). (2) DCQD plus conservative therapy versus conservative therapy (11 RCTs, 1,040 patients, SMD=-2.09 which favoured DCQD plus conservative therapy; 95% CI -3.04 to -1.15). Conclusion: DCQD combined with conservative therapy may increase the success rate of conservative therapy for intestinal obstruction significantly and can shorten the duration of postoperative ileus in patients undergoing abdominal surgery compared with conservative therapy alone.
    African Journal of Traditional, Complementary and Alternative Medicines 08/2014; 11(4-4):101-119. DOI:10.4314/ajtcam.v11i4.17 · 0.56 Impact Factor
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