Placebos and Principles: A Trial of Ondansetron
Authors: Marc L. Citron
Journal: Annals of Internal Medicine (1993)

Editorials15 March 1993Placebos and Principles: A Trial of OndansetronMarc L. Citron, MDMarc L. Citron, MDLong Island Jewish Medical Center, New Hyde Park, NY 11042.Author, Article, and Disclosure Informationhttps://doi.org/10.7326/0003-4819-118-6-199303150-00013 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail Special ethical concerns exist about the use of placebo controls. A placebo-controlled study must answer four questions: [1] Was any therapeutic intervention available that could be reasonably assumed to be less harmful than the placebo control? [2] Did the placebo control pose more than minimal risk to those patients? [3] Was the study designed in every way possible to minimize potential harm to the patients receiving placebo? [4] Were the patients fully and accurately informed of the additional risk of being in the placebo group?By answering these questions, the author evaluates a study comparing oral ondansetron to placebo for ...References1. Laszlo J. Nausea and vomiting as major complications of cancer chemotherapy. Drugs. 1983; 25(suppl 1):1-7. Google Scholar2. Tyers MB. Pharmacology and preclinical antiemetic properties of ondansetron. Semin Oncol. 1992; 19:1-8. Google Scholar3. Hainsworth J, Harvey W, Pendergrass K, Kasimis B, Oblon D, Monaghan G, et al. A single-blind comparison of intravenous ondansetron, a selective serotonin antagonist, with intravenous metoclopramide in the prevention of nausea and vomiting associated with high-dose cisplatin chemotherapy. J Clin Oncol. 1991; 9:721-8. Google Scholar4. De Mulder PH, Seynaeve C, Vermorken JB, van Liessum PA, Mols-Jevdevic S, Allman EL, et al. Ondansetron compared with high-dose metoclopramide in prophylaxis of acute and delayed cisplatin-induced nausea and vomiting. Ann Intern Med. 1990; 113:834-40. Google Scholar5. Marty M, Pouillart P, Scholl S, Droz JP, Azab M, Brion N, et al. Comparison of the 5-hydroxytryptamine3 (serotonin) antagonist ondansetron (GR38032F) with high-dose metoclopramide in the control of cisplatin-induced emesis. N Engl J Med. 1990; 322:816-21. Google Scholar6. Sledge Jr. GW, Einhorn L, Nagy C, House K. Phase III double-blind comparison of intravenous ondansetron and metoclopramide as antiemetic therapy for patients receiving multiple-day cisplatin-based chemotherapy. Cancer. 1992; 70:2524-8. Google Scholar7. Beck TM, Ciociola AA, Jones SE, et al. Efficacy of oral ondansetron in preventing emesis in outpatients receiving cyclophosphamide-based chemotherapy. Ann Intern Med. 1993; 118:407-13. Google Scholar8. Council on Ethical and Judicial Affairs, American Medical Association. Current opinions of the Council on Ethical and Judicial Affairs, 1992, Opinion 2.07, Clinical Investigation, p. 4, Chicago, Illinois. Google Scholar9. Gralla RJ. Nausea and vomiting. In: Cancer Principles and Practice of Oncology, Third edition. DeVita Jr. VT, Hellman S, Rosenberg SA, eds. Philadelphia: Lippincott; 1989; 2:2137, 2140. Google Scholar10. Budman D, Wood W, Korzun A, Henderson IC, Cooper R, Younger J, et al. Initial findings of CALGB 8541: A dose and dose intensity trial of cyclophosphamide (C), doxorubicin (A) and 5-fluorouracil (F) as adjuvant treatment of stage II, node positive female breast cancer. Proc Am Soc Clin Oncol. 1992; 11:51. Google Scholar11. Markman M, Sheidler V, Ettinger DS, Quaskey SA, Mellits ED. Antiemetic efficacy of dexamethasone: Randomized, double-blind, crossover study with prochlorperazine in patients receiving cancer chemotherapy. N Engl J Med. 1984; 311:549-52. Google Scholar12. Strum SB, McDermed JE, Opfell RW, Riech LP. Intravenous metoclopramide: an effective antiemetic in cancer chemotherapy. JAMA. 1982; 247:2683-6. Google Scholar13. Basurto C, Roila F, Bracarda S, Tonato M, Ballatori E, Del Favero A. A double-blind trial comparing antiemetic efficacy and toxicity of metoclopramide versus methylprednisolone versus domperidone in patients receiving doxorubicin chemotherapy alone or in combination with other antiblastic agents. Am J Clin Oncol. 1988; 11:594-6. Google Scholar14. Federal policy for the protection of human subjects. Final rule. Fed Regist. 49 CFR Part 11. 1991 Jun 18; 56(117):28013-4. Google Scholar Author, Article, and Disclosure InformationAuthors: Marc L. Citron, MDAffiliations: Long Island Jewish Medical Center, New Hyde Park, NY 11042.Corresponding Author: Marc L. Citron, MD, Division of Hematology/Oncology, Long Island Jewish Medical Center, New Hyde Park, NY 11042. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoEfficacy of Oral Ondansetron in the Prevention of Emesis in Outpatients Receiving Cyclophosphamide-based Chemotherapy Thomas M. Beck , Arthur A. Ciociola , Stephen E. Jones , Walter H. Harvey , N. Simon Tchekmedyian , Alex Chang , Daniel Galvin , Nan E. Hart , and Metrics Cited byEmployment of Substandard Antiemetic Prophylaxis in Recent Trials of Chemotherapy-Induced Nausea and VomitingThe placebo (I shall please) - is it so pleasing in children?Are more antiemetic trials with a placebo necessary? Report of patient data from randomized trials of placebo antiemetics with cisplatinEthical Issues regarding Study Designs Used in Serotonin-Antagonist Drug DevelopmentRandomized Controlled Trials in Inflammatory Bowel Diseases: The Case for the Positive ControlAssessment of Chemotherapy-Induced Emesis and Evaluation of a Reduced-Dose Intravenous Ondansetron Regimen in Pediatric Outpatients with LeukemiaThe Continuing Unethical Use of Placebo Controls 15 March 1993Volume 118, Issue 6Page: 470-471KeywordsCancer chemotherapyChemotherapyClinical trialsCyclophosphamideDrugsFood and Drug AdministrationInstitutional review boardsNauseaToxicityVomiting ePublished: 15 August 2000 Issue Published: 15 March 1993 Copyright & PermissionsCopyright © 1993 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...