Combining rigour with relevance: a novel methodology for testing Chinese herbal medicine
Combining rigour with relevance: a novel methodology for testing Chinese herbal medicine
Background: 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.
Method: 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.
Results: 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.
Conclusion: 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.
chinese herbal medicine, novel methodology, individualized decoctions, double blind randomized controlled trial, relevance and rigour
373-378
Flower, Andrew
5256a2c8-6e74-49be-acc8-463ed3c18c6a
Lewith, George
0fc483fa-f17b-47c5-94d9-5c15e65a7625
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
25 December 2010
Flower, Andrew
5256a2c8-6e74-49be-acc8-463ed3c18c6a
Lewith, George
0fc483fa-f17b-47c5-94d9-5c15e65a7625
Little, Paul
1bf2d1f7-200c-47a5-ab16-fe5a8756a777
Flower, Andrew, Lewith, George and Little, Paul
(2010)
Combining rigour with relevance: a novel methodology for testing Chinese herbal medicine.
Journal of Ethnopharmacology, 134 (2), .
(doi:10.1016/j.jep.2010.12.025).
(PMID:21187138)
Abstract
Background: 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.
Method: 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.
Results: 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.
Conclusion: 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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Published date: 25 December 2010
Keywords:
chinese herbal medicine, novel methodology, individualized decoctions, double blind randomized controlled trial, relevance and rigour
Organisations:
Primary Care & Population Sciences
Identifiers
Local EPrints ID: 197213
URI: http://eprints.soton.ac.uk/id/eprint/197213
ISSN: 0378-8741
PURE UUID: 35a8c22a-6179-4670-b750-923a5d21e4be
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Date deposited: 20 Sep 2011 12:53
Last modified: 14 Mar 2024 04:10
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Author:
Andrew Flower
Author:
George Lewith
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