Article

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: 16.1). 04/2006; 144(5):364-7.
Source: PubMed

ABSTRACT 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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    • "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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    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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    • "In fact collaborative partnership which displays a commitment by all parties in international research agreements to work together for common language and goals should be the way forward for ATM research and with sustained investment; it will become increasingly possible to conduct sound international scientific investigation on TM. Furthermore, sustainable collaborative research partnerships would benefit from robust and independent adverse-event reporting systems for herbal medicines so that the risk–benefit ratio for herbal medicine research can be more clearly defined as in reference [17] "
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    • "In fact collaborative partnership which displays a commitment by all parties in international research agreements to work together for common language and goals should be the way forward for ATM research and with sustained investment; it will become increasingly possible to conduct sound international scientific investigation on TM. Furthermore, sustainable collaborative research partnerships would benefit from robust and independent adverse-event reporting systems for herbal medicines so that the risk–benefit ratio for herbal medicine research can be more clearly defined as in reference [17] "
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    ABSTRACT: Traditional medicine (TM) has been described by the World Health Organisation (WHO) as one of the surest alternative means to achieve total health care coverage of the world's population. In most African societies, traditional medicine plays an important role in the lives of millions who cannot access western medicine. In some areas, TM is part of the first set of response mechanisms for medical emergencies whilst in others the whole health system of the community is hinged on medicines rooted in local practice and belief. Although the relevance and values of TM is begining to gain recognition, African traditional medicine (ATM) still faces some challenges which underscore its scrutiny. This paper thus analyses the issue of science, acceptance and support for successful implementation of ATM and present the contemporary measures that are being taken to raise its standard to the level of western medicine.
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