Article

Combining rigour with relevance: A novel methodology for testing Chinese herbal medicine. J Ethnopharmacol

Department of Primary Care, Southampton Medical School, University of Southampton, UK.
Journal of ethnopharmacology (Impact Factor: 3). 12/2010; 134(2):373-8. DOI: 10.1016/j.jep.2010.12.025
Source: PubMed

ABSTRACT

There is a need to develop an evidence base for Chinese herbal medicine (CHM) that is both rigorous and reflective of good practice. This paper proposes a novel methodology to test individualised herbal decoctions using a randomised, double blinded, placebo controlled clinical trial.
A feasibility study was conducted to explore the role of CHM in the treatment of endometriosis. Herbal formulae were pre-cooked and dispensed as individual doses in sealed plastic sachets. This permitted the development and testing of a plausible placebo decoction. Participants were randomised at a distant pharmacy to receive either an individualised herbal prescription or a placebo.
The trial met the predetermined criteria for good practice. Neither the participants nor the practitioner-researcher could reliably identify group allocation. Of the 28 women who completed the trial, in the placebo group (n=15) 3 women (20%) correctly guessed they were on placebo, 8 (53%) thought they were on herbs and 4 (27%) did not know which group they had been allocated to. In the active group (n=13) 2 (15%) though they were on placebo, 8 (62%) thought they were on herbs and 3 (23%) did not know. Randomisation, double blinding and allocation concealment were successful and the study model appeared to be feasible and effective.
It is now possible to subject CHM to rigorous scientific scrutiny without compromising model validity. Improvement in the design of the placebo using food colourings and flavourings instead of dried food will help guarantee the therapeutic inertia of the placebo decoction.

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    • "For the purposes of these guidelines the recommendations are: • to include herbal decoctions at some stage of the CHM research process. This may be as part of a clinical audit, prospective observational study, or case series but it has been shown that rigorous double-blinded RCTs are possible with individualised CHM decoctions (Flower et al., 2011; Lechner et al., 2011); • if it is not possible, for financial or pragmatic reasons, to use decoctions in a trial setting, then we recommend using concentrated powders derived from herbal decoctions, rather than simply aggregating the individual herbal powders. We consider that this will incorporate the traditional compositions of ingredients (formed during the preparation of the decoctions) that are probably important to the effectiveness and safety of CHM; • if this is not possible, and only aggregated individual herb powders should be used, then this should be clearly recorded in the report of the trial methodology. "
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    ABSTRACT: As part of the GP-TCM project a team of experienced clinical researchers and Chinese herbal, medicine (CHM) practitioners have developed clinical trial guidelines for CHM that combine an, appreciation for traditional methods of practice with detailed and practical advice on rigorous research, methodology. This paper presents the full account of this work that has previously only been published, as an executive summary. It introduces the practice of CHM and the key considerations that need to be, addressed whilst researching this traditional medical system. These guidelines emphasise the, importance of identifying best practice, and then developing and applying appropriate and rigorous, research methodologies to investigate CHM as a whole system. It is hoped that this will encourage a, thoughtful and meticulous process of investigation that will clarify the contribution that CHM can make, to our future healthcare. Innovative new approaches are considered including the application of the, new "omic" technologies and systems biology as a way of enhancing our understanding of traditional, practice. This article belongs to the Special Issue: Clinical Guidelines for Integrated Practice.
    Full-text · Article · Apr 2014 · European Journal of Integrative Medicine
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    • "Best practice of Chinese medicine could be subject to rigorous investigation. Rigour can be successfully combined with relevance (Flower et al., 2011). Another vital piece of the research puzzle is the growing realisation of the importance of qualitative research to capture the subtle, deep, and frequently unpredictable experiences of people receiving treatment. "

    Full-text · Article · Apr 2012 · Journal of Herbal Medicine
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    • "For the purposes of these guidelines the recommendations are: • to include herbal decoctions at some stage of the CHM research process. This may be as part of a clinical audit, prospective observational study, or case series but it has been shown that rigorous double-blinded RCTs are possible with individualised CHM decoctions (Flower et al., 2011; Lechner et al., 2011); • if it is not possible, for financial or pragmatic reasons, to use decoctions in a trial setting, then we recommend using concentrated powders derived from herbal decoctions, rather than simply aggregating the individual herbal powders. We consider that this will incorporate the traditional compositions of ingredients (formed during the preparation of the decoctions) that are probably important to the effectiveness and safety of CHM; • if this is not possible, and only aggregated individual herb powders should be used, then this should be clearly recorded in the report of the trial methodology. "
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    ABSTRACT: ETHNOGRAPHIC RELEVANCE: Clinical trials investigating Chinese herbal medicine (CHM) have been frequently criticised for their lack of scientific rigour. As part of the GP-TCM project a team of experienced clinical researchers and CHM practitioners have developed clinical trial guidelines for CHM that combine an appreciation for traditional methods of practice with detailed and practical advice on research methodology. This paper presents an executive summary of this work. It introduces the practice of CHM and the key considerations that need to be addressed whilst researching this traditional medical system. These guidelines emphasise the importance of identifying best practice, and then developing and applying appropriate and rigorous research methodologies to investigate CHM as a whole system. It is hoped that this will encourage a thoughtful and meticulous process of investigation that will clarify the contribution that CHM can make to our future healthcare. Innovative new approaches are considered including the application of the new "omic" technologies and systems biology as a way of enhancing our understanding of traditional practice.
    Full-text · Article · Dec 2011 · Journal of ethnopharmacology
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