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