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- Title
PLACEBO/NOCEBO RESPONSES IN CLINICAL TRIALS AND PRACTICE.
- Authors
Warner, J. O.
- Abstract
Clinicians have throughout the ages considered the enhancement of placebo effects to be part of the art of medicine. Studies to characterise placebo effects and those of its counterpart, nocebo, have identified several factors, most notably disease severity and efficiency of disease control during trial run-in periods. Milder disease or good disease control is associated with higher placebo benefits. Endogenous opioid and dopamine pathway activation have been associated with placebo responses, and genetic polymorphisms in these pathways may explain susceptibilities to placebo responsiveness. Trials in asthma have shown that placebo responses, while improving subjective symptoms, have much less effect on lung function. Giving a false sense of security to patients with severe asthma through the activation of endogenous opioids could lead to a lack of appreciation of its deterioration and could contribute to a proneness to fatality. The assumption that the placebo response is additive to that of active treatment is not proven, nor are there consistent placebo responders and non-responders. When interpreting the outcome of placebo-controlled clinical trials, design is paramount. Disease severity should be encompassed in power calculations. The run-in period should be long enough to titrate medications to the minimum required to maintain control. Having three concurrent treatment groups - active, placebo and non-intervention - can aid evaluation. Other designs may improve discrimination: these can include having a prolonged run-in on placebo with only placebo non-responders randomised to either continue placebo or commence active treatment." The take-home message is that there is more to placebo/nocebo than meets the eye!
- Subjects
PLACEBOS; NOCEBOS; TREATMENT effectiveness; CLINICAL trials; SYMPTOMS
- Publication
Current Allergy & Clinical Immunology, 2023, Vol 36, Issue 4, p242
- ISSN
1609-3607
- Publication type
Article