Literature DB >> 27188301

What questions can a placebo answer?

Spencer Phillips Hey1, Charles Weijer2.   

Abstract

The concept of clinical equipoise restricts the use of placebo controls in clinical trials when there already exists a proven effective treatment. Several critics of clinical equipoise have put forward alleged counter-examples to this restriction-describing instances of ethical placebo-controlled trials that apparently violate clinical equipoise. In this essay, we respond to these examples and show that clinical equipoise is not as restrictive of placebos as these authors assume. We argue that a subtler appreciation for clinical equipoise-in particular the distinction between de facto and de jure interpretations of the concept-allows the concept to explain when and why a placebo control may be necessary to answer a question of clinical importance.

Keywords:  Clinical equipoise; Placebo controls; Randomized controlled trials; Research ethics

Mesh:

Substances:

Year:  2016        PMID: 27188301     DOI: 10.1007/s40592-016-0057-z

Source DB:  PubMed          Journal:  Monash Bioeth Rev        ISSN: 1321-2753


  27 in total

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Authors:  Sean R Tunis; Daniel B Stryer; Carolyn M Clancy
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2.  International ethical guidelines for biomedical research involving human subjects.

Authors: 
Journal:  Bull Med Ethics       Date:  2002-10

3.  The Question of Clinical Equipoise and Patients' Best Interests.

Authors:  Spencer Phillips Hey; Robert D Truog
Journal:  AMA J Ethics       Date:  2015-12-01

4.  Assay sensitivity and the epistemic contexts of clinical trials.

Authors:  Spencer Phillips Hey; Charles Weijer
Journal:  Perspect Biol Med       Date:  2013       Impact factor: 1.416

5.  Equipoise and the dilemma of randomized clinical trials.

Authors:  Franklin G Miller; Steven Joffe
Journal:  N Engl J Med       Date:  2011-02-03       Impact factor: 91.245

6.  Inhibition of mutated, activated BRAF in metastatic melanoma.

Authors:  Keith T Flaherty; Igor Puzanov; Kevin B Kim; Antoni Ribas; Grant A McArthur; Jeffrey A Sosman; Peter J O'Dwyer; Richard J Lee; Joseph F Grippo; Keith Nolop; Paul B Chapman
Journal:  N Engl J Med       Date:  2010-08-26       Impact factor: 91.245

7.  Equivalence of St John's wort extract (Ze 117) and fluoxetine: a randomized, controlled study in mild-moderate depression.

Authors:  E Schrader
Journal:  Int Clin Psychopharmacol       Date:  2000-03       Impact factor: 1.659

Review 8.  Treatments for metastatic melanoma: synthesis of evidence from randomized trials.

Authors:  Philip Lui; Richard Cashin; Márcio Machado; Michiel Hemels; Patricia K Corey-Lisle; Thomas R Einarson
Journal:  Cancer Treat Rev       Date:  2007-10-04       Impact factor: 12.111

9.  A controlled trial of arthroscopic surgery for osteoarthritis of the knee.

Authors:  J Bruce Moseley; Kimberly O'Malley; Nancy J Petersen; Terri J Menke; Baruch A Brody; David H Kuykendall; John C Hollingsworth; Carol M Ashton; Nelda P Wray
Journal:  N Engl J Med       Date:  2002-07-11       Impact factor: 91.245

10.  How to increase value and reduce waste when research priorities are set.

Authors:  Iain Chalmers; Michael B Bracken; Ben Djulbegovic; Silvio Garattini; Jonathan Grant; A Metin Gülmezoglu; David W Howells; John P A Ioannidis; Sandy Oliver
Journal:  Lancet       Date:  2014-01-08       Impact factor: 79.321

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  1 in total

1.  Placebo comparator group selection and use in surgical trials: the ASPIRE project including expert workshop.

Authors:  David J Beard; Marion K Campbell; Jane M Blazeby; Andrew J Carr; Charles Weijer; Brian H Cuthbertson; Rachelle Buchbinder; Thomas Pinkney; Felicity L Bishop; Jonathan Pugh; Sian Cousins; Ian Harris; L Stefan Lohmander; Natalie Blencowe; Katie Gillies; Pascal Probst; Carol Brennan; Andrew Cook; Dair Farrar-Hockley; Julian Savulescu; Richard Huxtable; Amar Rangan; Irene Tracey; Peter Brocklehurst; Manuela L Ferreira; Jon Nicholl; Barnaby C Reeves; Freddie Hamdy; Samuel Cs Rowley; Naomi Lee; Jonathan A Cook
Journal:  Health Technol Assess       Date:  2021-09       Impact factor: 4.014

  1 in total

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