What is the research question? A case study in the early stages of design of an randomised controlled trial for a complementary therapy

Randomised controlled trials (RCTs) can be used to evaluate aspects of the effectiveness of complementary therapies. Given the individualised and non-blindable nature of many treatments, the design of such studies is often not trivial. One decision to be made is what specific research question is to be asked, of the many potential questions that could be asked. This paper describes discussions that took place during the design of a trial to evaluate the effectiveness of herbal practitioners for menopausal women, and illustrates the tribulations associated with such a process. Specifically, it discusses implications of the choice of control group. It is critically important that a relevant and answerable research question is posed. (C) 2003 Elsevier Science Ltd. All rights reserved.