Placebo-Controlled Trials
Authors: Maurie Markman
Journal: Annals of Internal Medicine (2001)

Letters3 July 2001Placebo-Controlled TrialsMaurie Markman, MDMaurie Markman, MDThe Cleveland Clinic Foundation; Cleveland, Ohio 44195 (Markman)Search for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-135-1-200107030-00023 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR:The debate over the ethics of randomized, placebo-controlled trials focused on clinical settings where treatment does not affect the patient's long-term health or where delay or omission of active treatment would not increase mortality or irreversible morbidity (1). Unfortunately, this discussion ignored the issue of the use of a placebo in randomized, controlled trials when an effective treatment known to prevent reversible but highly clinically relevant morbidity is available. A specific example graphically makes this point.In 1993, a randomized trial comparing oral ondansetron with placebo demonstrated that the serotonin antagonist significantly reduced emesis caused by moderately ...References1. Simon R. Are placebo-controlled clinical trials ethical or needed when alternative treatment exists? [Editorial]. Ann Intern Med. 2000;133:474-5. [PMID: 10975967] LinkGoogle Scholar2. Beck T, Ciociola A, Jones S, Harvey W, Tchekmedyian N, Chang A, et al . Efficacy of oral ondansetron in the prevention of emesis in outpatients receiving cyclophosphamide-based chemotherapy. The Ondansetron Study Group. Ann Intern Med. 1993;118:407-13. [PMID: 8439113] LinkGoogle Scholar3. Cassileth P, Lusk E, Torri S, DiNubile N, Gerson S. Antiemetic efficacy of dexamethasone therapy in patients receiving cancer chemotherapy. Arch Intern Med. 1983;143:1347-9. [PMID: 6347109] CrossrefMedlineGoogle Scholar4. Markman M, Sheidler V, Ettinger D, Quaskey S, Mellits E. Antiemetic efficacy of dexamethasone. Randomized, double-blind, crossover study with prochlorperazine in patients receiving cancer chemotherapy. N Engl J Med. 1984;311:549-52. [PMID: 6379459] CrossrefMedlineGoogle Scholar5. Markman M. When regulatory requirements conflict with ethical study design: the case of oral ondansetron. Cancer Invest. 1994;12:654-6. [PMID: 7994600] CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: The Cleveland Clinic Foundation; Cleveland, Ohio 44195 (Markman) PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoAre Placebo-Controlled Clinical Trials Ethical or Needed When Alternative Treatment Exists? Richard Simon 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 and Active-Control Trials in the Evaluation of New Treatments. Part 1: Ethical and Scientific Issues Robert Temple and Susan S. Ellenberg Metrics 3 July 2001Volume 135, Issue 1Page: 63KeywordsCancer chemotherapyClinical trialsDrugsMorbidityMortalityQuality of lifeRandomized trialsSerotonin ePublished: 3 July 2001 Issue Published: 3 July 2001 CopyrightCopyright © 2001 by American College of Physicians. All Rights Reserved.PDF DownloadLoading ...