The case for uncontrolled clinical trials: a starting point for the evidence base for CAM.

Clinical research into the effectiveness of any therapy usually progresses in a series of steps that are aimed at providing evidence that will lead to improved patient care. One important early step is the uncontrolled trial. Uncontrolled trials serve several crucial purposes, including establishing firmly that there is a clinical effect worth investigating, identifying the most suitable patients and the most appropriate treatments, and providing information on how large the effect might be. They can be conducted relatively easily by practitioners in the course of their normal work, and are an excellent first step for anyone interested in clinical research. Such studies are not only satisfying, but develop skills in searching the literature and writing protocols, and promote rigorous thinking and attention to detail. The ultimate purpose of uncontrolled trials is to facilitate subsequent definitive studies that will help define the place of CAM in health care.