EDITORIAL NOTE:

THE PRACTITIONER UNCONTROLLED TRIAL

White and Ernst make a strong case for the uncontrolled clinical trial as a starting point for the evidence base for Complementary and Alternative therapies.  They note that uncontrolled trials serve crucial purposes which include establishing that there is a clinical effect worth studying, identifying its nature and suitable patients and treatments.  Uncontrolled trials can be incorporated readily into a practitioners normal work and are an excellent first step for anyone interested in clinical research.  Ultimately it is of course desirable to conduct large randomised controlled trials (RCTs) but these are expensive and do not preclude starter studies of the uncontrolled variety.  Uncontrolled trials are in a sense pilot or feasibility studies to inform later controlled trials, and they will add to our knowledge though may not be conclusive.   They are likely to be conducted on a convenience sample i.e. the patients who are available with the relevant condition who may be unrepresentative but nevertheless allow an opportunity for assessment of treatment and some guidance in groups for whom it might be useful and who could be included in a RCT.  Uncontrolled clinical trials do not use a control group.  Nevertheless they may have a strict protocol of practice, they may measure results carefully and rigorously, and they can be pivotal in the research process.

The following study by Eddie Caldwell provides a model for starting the documentation of the uncontrolled trial.

*The Case for uncontrolled Trials: a starting point for the evidence base for CAM.

Complementary Therapies in Medicine 2001; 9; 111-115

Also published in:

The International Journal of Aromatherapy 2001; 11; 4; 201 205