With great interest, I have just finished reading a paper by Dr. Andrew Flower and colleagues. The concise, logical and very informative paper was most recently published in Journal of Ethnopharmacology 2011;134:373-378 (www.ncbi.nlm.nih.gov/pubmed/21187138). The central questions addressed by the authors are highly relevant to anyone who is interested in clinical studies of personalised Chinese herbal medicines, which are orally administered as traditional decoctions. It appears that the authors have indeed found a copiable protocol for randomised and double-blinded clinical trials in the above complex setting. Very well done indeed! In addition, the authors have also invented a carefully selected control decoction and augued that this control decoction could be used as an inert placebo control for clinical trials. Although this definitely represents a plausible effort on such a long-standing problem (placebo control for studies of decoctions), if the control decoction comprising of 9 mixed plant materials can be taken for granted as inert placebo indeed invites discussion. The control decoction contains many active chemicals such as flavonoids that might well be of potential therapeutic values in some diseases, even through the same mechanisms as the herbal medicines to be tested. If this is the case, the control might become invalid as a placebo. Nevertheless, the authors have noticed the challenges we are facing on the “placebo” issue as they have stated elsewhere “we are some way from developing valid, credible and reliable placebos for most CAM therapies” (http://www.ncbi.nlm.nih.gov/pubmed/20090354). Another important information worthy mentioning is their excellent efforts to interact with their national regulatory body, The Medicines and Healthcare products Regulatory Agency (MHRA) to get approval for their trials. As the proposed trial was an investigation of existing routine Chinese herbal medicine practice, it constituted a phase 4 not a phase 3 clinical trial. As the authors said, “This reduced the cost and the regulatory requirements for the trial and it facilitated final MHRA and ethical approval.” In summary, I strongly recommend GP-TCM members and friends to read this very interesting paper and leave your comments here. Thank you!
