Chapter 2 Methodology for Clinical Study Investigating Chinese Medicine

Background A new clinical trial guideline for Chinese Medicine (CM) was published in 2015, which incorporates the characteristics of traditional approaches of practice with the practical recommendations of rigorous research methodology. Objectives This chapter aimed to introduce the research methodology for CM practice and the key considerations that need to address in relation to the characteristics of CM as a whole system. Details This chapter includes the introduction of basic study design, key issues on planning, implementing, and analyzing and reporting a clinical study of CM. The principles of clinical study design, basic research methods for interventional studies (e.g., randomized controlled trial), observational studies (e.g. cohort study, case-control study, case series study and case report), and systematic reviews were introduced in the first section. For each type of study, research model, scope of application, merit and weakness were addressed in accordance with the characteristics of CM. In the second section, we introduce details of methods of planning (research question, study protocol, sample size, study settings, participants, comparisons, and outcome measures), implementing (allocation sequence generation, blinding method, ethical approval, bias control, data management and monitoring), and analyzing (statistical methods, analysis and interpretation of results) a CM clinical study. Adequate examples from previous publications are shown to give clues and deepen understanding on each issue. Conclusions It is our hope that this chapter will encourage a thoughtful and meticulous process of investigation to provide reliable evidence for CM therapies for better health care.