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

Abstract

Evidence-based traditional Chinese medicine is attainable. With good planning and a positive attitude, the remedies used in traditional Chinese medicine (TCM) and Chinese proprietary medicines can be studied at a standard acceptable to modern science. The identification of an active principal should not delay the search for effective remedies from the TCM pharmacopoeia. Herbal 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 treatment and placebo arms can allow for the individualization of treatments by TCM practitioners. However, clearly defined treatments are required and should be recorded 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 natural ingredients must be used without adulteration or erroneous substitution. Evidence of safety in man is essential, and in lieu of data from formal toxicity studies, clear, convincing, and impartial evidence of safety is needed based on their long-term use in mainstream TCM practice backed up by publications in the Chinese medical/scientific literature. (C) 2000 the American College of Clinical Pharmacology.