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Research: LA VAQUE and ROSSITER,
Listed in Issue 74
Abstract
LA VAQUE and ROSSITER, Clinical Psychophysiology Center, Rogers Memorial Hospital, Wilwaukee, Wisconsin 53704, USA, tlavaque@gbonline.com, discuss the problems of designing clinical trials with meaningful control groups, particularly in relation to investigating psychophysiological therapies, while adhering to current ethical principles of conduct for biomedical research.
Background
It is considered unethical to carry out clinical studies using placebo or sham procedures (i.e. interventions considered to have no active treatment effect) as control treatments, when safe and effective standard therapies/treatments are available . On the other hand, trials investigating psychophysiological therapies [such as biofeedback or hypnosis] are often criticised for not having a placebo or sham treatment group with which to compare the experimental intervention.
Methodology
Results
Conclusion
The writers conclude that when clinical studies involve patients with a disorder for which there is a known effective treatment, then this should be the comparator group (i.e. active treatment control – examining treatment equivalence). However, when studies investigate experimental treatments for disorders for which there is no known effective treatment, then a sham- or placebo -controlled comparator group is acceptable .
References
La Vaque TJ, Rossiter T. The ethical use of placebo controls in clinical research: the Declaration of Helsinki. Applied Psychophysiology and Biofeedback 26 (1): 23-37. Mar 2001.
Comment
See comments above.
