Placebos, Active Placebos, and Clinical Trials

The Code of Ethics of the American Medical Association does not prohibit the prescribing of PBOs, but it states that it must be done with the patient's consent.1 Although this is feasible in the context of research, it likely is counterproductive in the clinical setting. The Group for the Advan...

Full description

Saved in:
Bibliographic Details
Published in:Clinical therapeutics 2017-03, Vol.39 (3), p.451-454
Main Author: Shader, Richard I, MD
Format: Article
Language:English
Subjects:
Amitriptyline
Anemia
Antipsychotics
Arches
Atropine
Chemical compounds
Children
Clinical medicine
Clinical trials
Cognitive ability
Deception
Direct reduction
Documents
Ethical standards
Ethics
Excipients
Headache
Health promotion
Innovations
Internal Medicine
Media
Medical Education
Mental depression
Mental disorders
Migraine
Nocebos
Packaging
Pain
Patients
Pernicious anemia
Pharmacology
Phenobarbital
Phenothiazine
Placebo effect
Placebos
Prevention
Psychiatry
Psychotherapy
Reagents
Research design
Schizophrenia
Shot
Side effects
Statistical analysis
Sulfates
Tactile stimuli
Vitamin B12
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:The Code of Ethics of the American Medical Association does not prohibit the prescribing of PBOs, but it states that it must be done with the patient's consent.1 Although this is feasible in the context of research, it likely is counterproductive in the clinical setting. The Group for the Advancement of Psychiatry's Committee on Research wondered whether patients in blinded studies would be influenced if they felt no effects from a trial agent and whether clinician prescribers and assessors would be biased if the experimental agent produced side effects while the PBO did not.3 In other words, they wondered whether double-blind studies using inert PBOs were truly blinded. In concert with this concern, my colleagues and I developed an “active PBO,” low doses of phenobarbital and atropine sulfate, for use in clinical trials of phenothiazines in patients with schizophrenia.4 We subsequently used it in a double-blind study.5 During this clinical trial, we also studied the treatment-assignment guesses made by the clinical staff and found that this was a truly blinded study.6 From my perspective, it is regrettable that active PBOs are only rarely incorporated into clinical trials. Treatments and procedures for administration, including strategies for packaging and "blinding," must also be included. Since we has asked a number of his colleagues to contribute their perspectives about PBOs and new studies that elucidate what PBOs do and do not do.12-17 In his own contribution,13 Dr. Dodd also discusses processes implicated in the nocebo reaction, a term coined in 1961 by Walter...
ISSN:0149-2918
1879-114X
DOI:10.1016/j.clinthera.2017.02.001