Placebo-Controlled Trials
Authors: Benjamin Djulbegovic
Journal: Annals of Internal Medicine (2001)

Letters3 July 2001Placebo-Controlled TrialsBenjamin Djulbegovic, MDBenjamin Djulbegovic, MDH. Lee Moffitt Cancer Center and Research Institute; University of South Florida (Djulbegovic)Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-135-1-200107030-00022 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:I was surprised that in a series of four articles devoted to the ethics of placebo-controlled trials in the 19 September 2000 issue of Annals, including those by Temple and Ellenberg (1, 2), none referred to equipoise, a fundamental ethical and scientific principle of human experimentation (3). This principle states that the patient should be enrolled in a randomized, controlled trial only if there is substantial uncertainty ("equal bet") about which of the trial treatments would benefit a patient most (3). This principle applies to any randomized trial, regardless of whether it is placebo-controlled. However, it is ...References1. Temple R, Ellenberg SS. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 1: ethical and scientific issues. Ann Intern Med. 2000;133:455-63. [PMID: 10975964] LinkGoogle Scholar2. Ellenberg SS, Temple R. Placebo-controlled trials and active-control trials in the evaluation of new treatments. Part 2: practical issues and specific cases. Ann Intern Med. 2000;133:464-70. [PMID: 10975965] LinkGoogle Scholar3. Edwards S, Lilford R, Braunholtz D, Jackson J, Hewison J, Thornton J. Ethical issues in the design and conduct of randomised controlled trials. Health Technol Assess. 1998;2:1-132. [PMID: 10194615] CrossrefMedlineGoogle Scholar4. Lilford RJ, Djulbegovic B. Declaration of Helsinki should be strengthened. Equipoise is essential principle of human experimentation [Letter]. BMJ. 2001;322:299-300. [PMID: 11157551] MedlineGoogle Scholar5. Djulbegovic B, Lacevic M, Cantor A, Fields K, Bennett C, Adams J, et al . The uncertainty principle and industry-sponsored research. Lancet. 2000;356:635-8. [PMID: 10968436] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Benjamin Djulbegovic, MDAffiliations: H. Lee Moffitt Cancer Center and Research Institute; University of South Florida (Djulbegovic) PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoPlacebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 1: Ethical and Scientific Issues Robert Temple and Susan S. Ellenberg Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 2: Practical Issues and Specific Cases Susan S. Ellenberg and Robert Temple Placebo-Controlled Trials Robert Temple and Susan S. Ellenberg Metrics Cited byTransforming masculine norms to improve men's contraceptive acceptance: results from a pilot intervention with men in western KenyaA Qualitative Investigation of the Impact of a Livelihood Intervention on Gendered Power and Sexual Risk Behaviors Among HIV-Positive Adults in Rural KenyaEthische Implikationen methodischer VorgabenEthical guidelines in psychiatric researchGeneral Overview of Ethical Issues in Psychiatric TreatmentSexual Scripts of Women: A Longitudinal Analysis of Participants in a Gender-Specific HIV/STD Prevention InterventionRevisiting "Success": Posttrial Analysis of a Gender-Specific HIV/STD Prevention InterventionEthische Implikationen plazebokontrollierter Prüfungen von PsychopharmakaEthical dilemmas encountered during clinical drug trialsMagnitude of the placebo effect in randomized trials of antiepileptic agents 3 July 2001Volume 135, Issue 1Page: 62-63KeywordsPatient advocacyRandomized trials ePublished: 3 July 2001 Issue Published: 3 July 2001 Copyright & PermissionsCopyright © 2001 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...