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: 2.94). 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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    • "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. "
    04/2012; 2(1):23–25. DOI:10.1016/j.hermed.2012.01.001
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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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