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

作者: Jeremy Howick , None

DOI: 10.1080/15265160903090041

关键词:

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

参考文章(94)
Paul C Hébert, George Wells, Morris A Blajchman, John Marshall, Claudio Martin, Giuseppe Pagliarello, Martin Tweeddale, Irwin Schweitzer, Elizabeth Yetisir, Transfusion Requirements in Critical Care Investigators for the Canadian Critical Care Trials Group, A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care The New England Journal of Medicine. ,vol. 340, pp. 409- 417 ,(1999) , 10.1056/NEJM199902113400601
Iain Chalmers, Imogen Evans, Hazel Thornton, Paul Glasziou, Testing Treatments: Better Research for Better Healthcare ,(2006)
Writing Group for the Women's Health Initiative Investigators, Writing Group for the Women's Health Initiative Investigators, None, Risks and benefits of estrogen plus progestin in healthy postmenopausal women: Principal results from the Women's Health Initiative randomized controlled trial JAMA. ,vol. 288, pp. 321- 333 ,(2002) , 10.1001/JAMA.288.3.321
Louis Lasagna, The controlled clinical trial: Theory and practice Journal of Chronic Diseases. ,vol. 1, pp. 353- 367 ,(1955) , 10.1016/0021-9681(55)90090-4
S. H. Mitchell, C. L. Laurent, H. de Wit, Interaction of expectancy and the pharmacological effects of d-amphetamine: subjective effects and self-administration. Psychopharmacology. ,vol. 125, pp. 371- 378 ,(1996) , 10.1007/BF02246020
Sherman Ross, Arnold D. Krugman, Samuel B. Lyerly, And Dean J. Clyde, Drugs and Placebos: A Model Design: Psychological Reports. ,vol. 10, pp. 383- 392 ,(1962) , 10.2466/PR0.1962.10.2.383
Michael D E Goodyear, Karmela Krleza-Jeric, Trudo Lemmens, The Declaration of Helsinki. BMJ. ,vol. 335, pp. 624- 625 ,(2007) , 10.1136/BMJ.39339.610000.BE