Evaluating complementary therapies for use in the National Health Service: 'Horses for courses'. Part 1: The design challenge

Author(s): THOMAS, K.

Abstract: Despite the amount that has been written about research methodologies for evaluating medical interventions (conventional and non-conventional), there remains a need to clarify which specific research designs are most appropriate and under what circumstances. This paper, the first of two, discusses a number of substantial problems with using a classical randomized controlled clinical trial design for assessing complex interventions, such as many complementary therapies, and identifies a set of design challenges that arise from these problems. In particular, we recognize the need to retain randomization in the research design. Despite the practical difficulties that can arise, the arguments for randomization are compelling. However, we argue for the use of randomization in a way that maximizes the proportion of the population that is included in the evaluation and builds on patients' preferences as much as possible. Additionally, we argue for a design that leaves practitioners free to give individualized treatments as appropriate and enables them to develop their relationship with each patient without constraint. In effect, we want to be able to evaluate the therapy or service delivered under 'normal' service conditions as near as is possible. Our second paper argues that the search for appropriate methods need not be a 'one horse race' and describes two trial designs that appear to meet these challenges without sacrificing methodological rigour.

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