Alternative therapies and medical science: Designing clinical trials of alternative/complementary medicines - Is evidence-based traditional Chinese medicine attainable?

Evidence-based traditional Chinese medicine is attainable. With good planni ng and a positive attitude, the remedies used in traditional Chinese medici ne (TCM) and Chinese proprietary medicines can be studied at a standard acc eptable to modern science. The identification of an active principal should not delay the search for effective remedies fi om the TCM pharmacopoeia. H erbal mixtures can be validly tested to establish their efficacy. Problems with potential batch-to-batch variation can be circumvented by appropriate randomization. Subsequent independent screening and randomization to treatm ent and placebo arms can allow for the individualization of treatments by T CM practitioners. However, clearly defined treatments are required and shou ld be re-corded in a manner that enables other suitably trained researchers to reproduce them reliably (e.g., using prescriptions in Chinese). Quality control of TCM is a prerequisite of credible clinical trials. Correct natu ral ingredients must be used without adulteration or erroneous substitution . Evidence of safety in man is essential, and in lieu of data from formal t oxicity studies, clear convincing, and impartial evidence of safety is need ed based on their long-term use in mainstream TGM practice backed up by pub lications in the Chinese medical/scientific literature. (C) 2000 the Americ an College of Clinical Pharmacology.