© 2003 by Oxford University Press
Journal of the National Cancer Institute, Vol. 95, No. 1, 2-3,
January 1, 2003
© 2003 Oxford University Press
EDITORIAL |
Implications of Effects in Placebo Groups
Correspondence to: Robert J. Temple, M.D., Center for Drug Evaluation and Research, 5600 Fishers Lane, HFD-40, Rockville, MD 20857 (e-mail: temple@cder.fda.gov).
| The first 10% of the full text of this article appears below. |
In this issue of the Journal, Chvetzoff and Tannock (1) review the responses of patients on placebo or best supportive care in 47 randomized trials in a variety of tumors to assess placebo effects in oncology. In considering the implications of this work, it is unfortunate that the name for the effect of drug-taking itself, the placebo effect (i.e., an effect unrelated to what the drug does), is the same as the name of dummy drug, the placebo, used to blind (mask) the study treatments. This nomenclature has led to confusion between the "placebo effect" and the "effect in the placebo group." Effects of the latter type include, as the authors recognize, not only placebo effects but also changes resulting from the natural course of the disease (which are very important in most symptomatic conditions), regression to the mean, and a variety of nonspecific influences, some of