Literature DB >> 19998192

Questioning the methodologic superiority of 'placebo' over 'active' controlled trials.

Jeremy Howick1.   

Abstract

A resilient issue in research ethics is whether and when a placebo-controlled trial (PCT) is justified if it deprives research subjects of a recognized treatment. The clinicians' moral duty to provide the best available care seems to require the use of 'active' controlled trials (ACTs) that use an established treatment as a control whenever such a therapy is available. In another regard, ACTs are supposedly methodologically inferior to PCTs. Hence, the moral duty of the clinical researcher to use the best methods will favor PCTs. In this target article, I analyze the three reasons for believing that ACTs are inferior to PCTs namely: 1) ACTs lack 'assay sensitivity'; 2) ACTs do not measure absolute effect size; and 3) ACTs require more participants; and I contend that none are acceptable. Consequently the tension between clinical and research ethics dissolves: the moral duty of the clinician to avoid PCTs is unopposed by methodological considerations.

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Year:  2009        PMID: 19998192     DOI: 10.1080/15265160903090041

Source DB:  PubMed          Journal:  Am J Bioeth        ISSN: 1526-5161            Impact factor:   11.229


  13 in total

1.  Evidence-based mechanistic reasoning.

Authors:  Jeremy Howick; Paul Glasziou; Jeffrey K Aronson
Journal:  J R Soc Med       Date:  2010-11       Impact factor: 5.344

2.  Are explanatory trials ethical? Shifting the burden of justification in clinical trial design.

Authors:  Kirstin Borgerson
Journal:  Theor Med Bioeth       Date:  2013-08

3.  Placebo orthodoxy and the double standard of care in multinational clinical research.

Authors:  Maya J Goldenberg
Journal:  Theor Med Bioeth       Date:  2015-02

4.  Guided Imagery for Total Knee Replacement: Responses to an Audiobook Placebo Treatment.

Authors:  Wendy Umberger; Claire Burke Draucker; Ann Jacobson
Journal:  West J Nurs Res       Date:  2019-06-04       Impact factor: 1.967

Review 5.  What questions can a placebo answer?

Authors:  Spencer Phillips Hey; Charles Weijer
Journal:  Monash Bioeth Rev       Date:  2016-03

6.  Placebo Controlled Trials: Interests of Subjects versus Interests of Drug Regulators.

Authors:  Teguh Haryo Sasongko; Nor Hayati Othman; Nik Hazlina Nik Hussain; Yeong Yeh Lee; Sarimah Abdullah; Azlan Husin; Hans Van Rostenberghe
Journal:  Malays J Med Sci       Date:  2017-08-18

7.  Local IRBs vs. federal agencies: shifting dynamics, systems, and relationships.

Authors:  Robert L Klitzman
Journal:  J Empir Res Hum Res Ethics       Date:  2012-07       Impact factor: 1.742

Review 8.  Are treatments more effective than placebos? A systematic review and meta-analysis.

Authors:  Jeremy Howick; Claire Friedemann; Maria Tsakok; Robert Watson; Teresa Tsakok; Jennifer Thomas; Rafael Perera; Susannah Fleming; Carl Heneghan
Journal:  PLoS One       Date:  2013-05-15       Impact factor: 3.240

9.  Placebo use in the United kingdom: results from a national survey of primary care practitioners.

Authors:  Jeremy Howick; Felicity L Bishop; Carl Heneghan; Jane Wolstenholme; Sarah Stevens; F D Richard Hobbs; George Lewith
Journal:  PLoS One       Date:  2013-03-20       Impact factor: 3.240

10.  Patient preferences and performance bias in a weight loss trial with a usual care arm.

Authors:  Jim McCambridge; Annik Sorhaindo; Alan Quirk; Kiran Nanchahal
Journal:  Patient Educ Couns       Date:  2014-01-13
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