Placebo effect and randomized clinical trials

@article{Elander1995PlaceboEA,
  title={Placebo effect and randomized clinical trials},
  author={G. Elander and G. Hermer{\'e}n},
  journal={Theoretical Medicine},
  year={1995},
  volume={16},
  pages={171-182}
}
The achievement of optimal therapeutic results presupposes the use of appropriate treatment combined with maximal utilization of placebo effects. These aims may sometimes be difficult to satisfy in randomized clinical trials (RCTs). The question thus arises whether there is a conflict between the goals of therapy and those of experimental research; and if so, to what extent, and how is it handled in practice by clinicians and researchers. Various ethical problems have been discussed in several… Expand

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References

SHOWING 1-10 OF 23 REFERENCES
Consent and randomized clinical trials: are there moral or design problems?
  • L. Kopelman
  • Psychology, Medicine
  • The Journal of medicine and philosophy
  • 1986
TLDR
It is found that some, but not all, RCTs, are intrinsically problematic but that sufficient reason has not been found to hold all RCT schemas as intrinsically morally troubling. Expand
A new design for randomized clinical trials.
  • M. Zelen
  • Medicine
  • The New England journal of medicine
  • 1979
TLDR
This paper proposes a new method for planning randomized clinical trials, especially suited to comparison of a best standard or control treatment with an experimental treatment, which has the advantage that, before providing consent, a patient will know whether an experimental therapy is to be used. Expand
Ethics of the randomized clinical trial.
  • A. Schafer
  • Medicine
  • The New England journal of medicine
  • 1983
TLDR
Some of the major ethical problems posed by the randomized clinical trial are distinguished, to set out some of the principal considerations. Expand
Effects of placebo administration and occurrence of toxic reactions.
TLDR
The present study was undertaken in an attempt to provide an approach for small-scale studies that would be as foolproof as possible and one that would have validity even when the sought-for therapeutic effects are not accessible to quantitative measurement. Expand
NONBLIND PLACEBO TRIAL: AN EXPLORATION OF NEUROTIC PATIENTS' RESPONSES TO PLACEBO WHEN ITS INERT CONTENT IS DISCLOSED.
  • L. Park, L. Covi
  • Psychology, Medicine
  • Archives of general psychiatry
  • 1965
TLDR
The placebo effect should be looked upon as an epiphenomenon of complicated psychological processes, which are far more important than the disarmingly simple means utilized for its realization. Expand
The powerful placebo.
  • H. Beecher
  • Medicine
  • Journal of the American Medical Association
  • 1955
TLDR
It is interesting that Pepper could say as recently as 10 years ago "apparently there has never been a paper published discussing the important subject of the placebo," but in 1953 Gaddum1 said: Such tablets are sometimes called placebos, but it is better to call them dummies. Expand
A conditioned response model of the placebo effect
TLDR
A model of the placebo response as a conditioned response(CR) is presented and predictions from this model are listed and the relationship between placebo responding and hypnotizability is discussed. Expand
Partial antagonism of placebo analgesia by naloxone
TLDR
Although naloxone alone had no effect on the experimental pain, nalOXone diminished the analgesic effectiveness of the placebo, suggesting that endogenous opioids are involved in producing placebo‐induced analgesia. Expand
Physicians' reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer.
TLDR
Investigation into the behavioral aspects of the investigator-patient relationship is particularly pressing, since fear of change in this relationship was the most common reason given for not entering eligible patients in the trial. Expand
[Nocebo--the antipode to placebo].
TLDR
It is postulated that noradrenergic neurons in locus coeruleus in the brain stem are involved in the production of nocebo-effects, and that the "placebo-system" and the "nocebosystem" exert a reciprocal inhibition at a brainstem level. Expand
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