Key considerations for conducting Chinese medicine clinical trials in hospitals

Chinese medicine (CM) treatments, including acupuncture, herbal medicine, remedial manual therapy, and exercise therapy (Tai Chi) are growing in popularity [1-3]. At the same time the healthcare community have begun to acknowledge the preferences of patients to receive treatment with CM in the United Kingdom, United States and Australia [4-7]. In Australia, CM practitioners must be registered nationally by the Chinese Medicine Board of Australia through the Australian Health Practitioners Regulation Agency in order to practice acupuncture and prescribe Chinese herbal medicine [8].The practice and paradigmatic philosophies of CM differ from those of Western medicine (WM). Traditional CM diagnostic methods consider factors such as the environment, seasons, emotions, diet, and lifestyle. In addition WM diagnostic approaches are also used by CM practitioners to provide a comprehensive diagnosis and individualised treatment plan. In contrast, WM focuses on pathological processes and uses diagnostic instruments or tests or both to classify illness, and places less of an emphasis on a person’s interaction with the environment. These differences may create gaps in communication between the disciplines; however, recently cooperation has grown [9].Evidence-based medicine (EBM) including randomized controlled trials (RCT) is likely to bridge the gap further between CM and WM. Increasing numbers of RCTs are being undertaken to determine the efficacy and safety of CM interventions [10]. CM researchers have been striving to achieve high standards of scientific rigor through RCTs. However, this has presented challenges in harmonizing CM theory and the RCT design required to enable effective translation [11].Given the relatively short history of RCTs in CM outside China, a substantial proportion of CM studies were usually conducted in universities or community clinics. In Australia, hospitals are increasingly involved in clinical studies since the introduction of national strategie