Towards a model for planning clinical research in oriental medicine

Background: Oriental medicine (OM) is widely practiced internationally and embraces many schools of thought. Western medical research is currently struggling to understand OM in purely biomedical terms, with limited success. Objective: We propose a research model for applying Western research methodologies to OM in a way that respects its theory and modes of clinical application. This would facilitate systematic investigations of OM's specific assumptions and make explicit the way OM studies could build on each other. Methods: To develop this model, the authors extracted key assumptions of Western research methodology germane to clinical research, put them in a developmentally logical sequence, and related them to the diagnostic and clinical processes of OM. Results: The model categorizes studies into seven levels. Foundation studies (level one) establish the conceptual basis for OM research by establishing the internal validity of its basic "truth statements." Measurement studies (level two) determine how OM identifies and measures diagnostic indicators, treatment outcomes, and other basic aspects of health. Group studies (level three) describe populations in ways meaningful to their health. Pattern/diagnosis studies (level four) identify and define OM patterns of disharmony. Treatment technique studies (level five) describe particular techniques or principles of treatment, their indications, and rationale. Treatment effectiveness studies (level six) evaluate techniques of treatment, often by comparing the results of one technique with those of another in similar patients. Systematic reviews (level seven) draw together studies on the same topic to see if conclusions are thereby strengthened. Conclusion: The levels can be used to establish relationships between already published studies, determine if sufficient background research has been done to enable a study idea to be carried out, and generate ideas for future studies.