Normally, clinical research of all types of conventional and traditional medicine considers both efficacy and safety, and is conducted according to WHO’s guidelines for good clinical practice and the Declaration of Helsinki (see Annex VI). Safety evaluation, however, may not be the main focus of clinical research in traditional medicine, because of the long history of traditional medicine. The information here provides further details to the relevant sections dealing with clinical trials in the assessment of herbal medicines (Part 1) and traditional procedure-based therapies (Part 2).
In addition to evaluating the safety and efficacy of traditional medicine through clinical trials, there may be a number of different objectives when evaluating traditional medicine through clinical research, as when using clinical research to evaluate conventional medicine. Some of the objectives specific to the assessment of traditional medicine through clinical research are to:
• evaluate traditional medicine in its own theoretical framework (e.g. mechanistic studies);
• evaluate traditional medicine in the theoretical framework of conventional medicine (e.g. mechanistic studies);
• compare the efficacy of different systems of traditional medicine and/or conventional medicine; and
• compare the efficacy of different traditional practices within a system of traditional medicine.