Journal of Clinical Epidemiology
Volume 53, Issue 2 , Pages 157-161 , February 2000

Why use placebos in clinical trials? A narrative review of the methodological literature

  • Andrew J. Vickers

      Affiliations

    • Integrative Medicine Service and Biostatistics Service, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 11215, USA
    • Corresponding Author InformationCorresponding author. Tel.: 1-212-639-8629; fax: 1-212-794-5851.
  • ,
  • Anton J.M. de Craen

      Affiliations

    • Department of Clinical Epidemiology, Leiden University Medical Centre, Leiden, Netherlands

Received 20 May 1998 ,Revised 16 June 1999 ,Accepted 23 June 1999.

References 

  1. Ho KH, Hashish I, Salmon P, Freeman R, Harvey W. Reduction of post-operative swelling by a placebo effect. J Psychosom Res. 1988;32:197–205
  2. Morgan JP, Dickey JL, Hunt HH, Hudgins PM. A controlled trial of spinal manipulation in the management of hypertension. J Am Osteopath Assoc. 1985;85:308–313
  3. Kokjohn K, Schmid DM, Triano JJ, Brennan PC. The effect of spinal manipulation on pain and prostaglandin levels in women with primary dysmenorrhea. J Manipulative Physiol Ther. 1992;15:279–285
  4. Moseley JB, Wray NP, Kuykendall D, Willis K, Landon G. Arthroscopic treatment of ostearthritis of the knee (a prospective, randomized, placebo-controlled study). Am J Sports Med. 1996;24:28–34
  5. Campbell A. Hunting the snark (the quest for the perfect acupuncture placebo). Acupunc Med. 1991;9:83–84
  6. Rothman KJ, Michels KB. The continuing unethical use of placebo controls. N Engl J Med. 1994;33:394–397
  7. Clark PI, Leaverton PE. Scientific and ethical issues in the use of placebo controls in clinical trials. Annu Rev Public Health. 1994;15:19–38
  8. Ernst E, Resch KL. Concept of true and perceived placebo effects. BMJ. 1995;311:551–553
  9. Haegerstam G, Huitfeldt B, Nilsson BS, et al.  Placebo in clinical drug trials—a multidisciplinary review. Methods Find Exp Clin Pharmacol. 1982;4:261–278
  10. Keating JC. The placebo issue and clinical research. J Manipulative Physiol Ther. 1987;10:329–332
  11. Klerman GL. Scientific and ethical considerations in the use of placebo controls in clinical trials in psychopharmacology. Psychopharmaco Bull. 1986;22:25–29
  12. Leber P. The placebo control in clinical trials (a view from the FDA). Psychopharmaco Bull. 1986;22:30–32
  13. Makuch RW, Johnson MF. Dilemmas in the use of active control groups in clinical research IRB Rev Hum Subjects Res 1989;11:1–5.
  14. Pledger GW, Hall D. Active control trials: Do they address the efficacy issue?. Proc Am Stat Soc 1986:1–10.
  15. Rickels K. Use of placebo in clinical trials. Psychopharmacol Bull. 1986;22:19–24
  16. Temple R. Government viewpoint of clinical trials. Drug Inform J. 1982;16:10–17
  17. Altman DG. Practical statistics for medical research. London: Chapman and Hall; 1991;
  18. Campbell MJ, Machin D. Medical Statistics (a Commonsense Approach). Chichester: John Wiley and Sons; 1993;
  19. Feinstein AR. Clinical Epidemiology. The Architecture of Clinical Research. Philadelphia, PA: W.B. Saunders Company; 1985;
  20. Fletcher RH, Fletcher SW, Wagner EH. Clinical Epidemiology. The Essentials. 3rd ed. Baltimore, MD: Williams & Wilkins; 1996;
  21. Gordis L. Epidemiology. Philadelphia: W.B.G. Saunders Company; 1996;
  22. Greenberg RS. Medical Epidemiology. Norwalk, CT: Appleton & Lange; 1993;
  23. Hennekens CH, Buring JE. Epidemiology in Medicine. Boston, MA: Little, Brown and Company; 1987;
  24. Hulley SB, Cummings SR. Designing Clinical Research. Baltimore, MD: Williams & Wilkins; 1988;
  25. Knapp RG, Miller MC. Clinical Epidemiology and Biostatistics. Baltimore, MD: Williams & Wilkins; 1992;
  26. Kramer MS. Clinical Epidemiology and Biostatistics. Berlin/Heidelberg: Springer-Verlag; 1988;
  27. Meinert CL. Monographs in Epidemiology and Biostatistics. Clinical Trials. Design, Conduct, and Analysis (vol. 11). New York: Oxford University Press; 1986;
  28. Morton RF, Hebel JR, McCarter RJ. A Study Guide to Epidemiology and Biostatistics. 3rd ed. Gaithersberg, MD: Aspen Publishers, Inc; 1989;
  29. Pocock SJ. Clinical trials (A Practical Approach). Chichester: John Wiley and Sons; 1983;
  30. Sackett DL, Haynes RB, Guyatt GH, Tugwell P. Clinical Epidemiology. Boston, MA: Little, Brown and Company; 1991;
  31. Spilker B. Guide to Clinical Studies and Developing Protocols. New York: Raven Press; 1984;
  32. Weiss NS. Monographs in Epidemiology and Biostatistics. Clinical Epidemiology (The Study of the Outcome of Illness (vol. 11)). New York: Oxford University Press; 1986;
  33. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. JAMA. 1995;273:408–412
  34. Colditz GA, Miller JB, Mosteller F. How study design affects outcomes in comparisons of therapy. I: Medical. Stat Med. 1989;8(4):441–454
  35. Turner JA, Deyo RA, Loeser JD, Von Korff M, Fordyce WE. The importance of placebo effects in pain treatment and research. JAMA. 1994;271:1609–1614
  36. Gracely RH, Dubner R, Deeter WR, Wolskee PJ. Clinicians' expectations influence placebo analgesia. Lancet. 1985;i:43
  37. Pastorello EA, Codecasa LR, Gerosa A, Buonocore E, Sillano V, Zanussi C. The role of suggestion in asthma. I. Effects of inactive solution on bronchial reactivity under bronchoconstrictor or bronchodilator suggestion. Ann Allergy. 1987;59:336–338
  38. de Craen AJM, Roos PJ, de Vries AL, Kleijnen J. Effects of colour of drugs (systematic review of perceived effect of drugs and of their effectiveness). BMJ. 1996;313:1624–1626
  39. Voudouris NJ, Peck CL, Coleman G. The role of conditioning and verbal expectancy in the placebo response. Pain. 1990;43:121–128
  40. Silagy C, Mant D, Fowler G, Lancaster T. Nicotine replacement therapy for smoking cessation. In: Lancaster T, Silagy C, Fullerton D (editors) Tobacco Addiction Model of The Cochrane Database of Systematic Reviews. Available in The Cochrane Library [database on disk and CDROM] The Cochrane Collaboration; Issue 4. Oxford: Update Software, 1998.
  41. de Craen AJM, Vickers AJ, Tijssen JGP, Kleijnen J. The number-needed-to-treat and placebo-controlled trials. Lancet. 1998;351:310
  42. de Jonge JW, Knottnerus JA, van Zutphen WM, de Bruijne GA, Struijker Boudier HAJ. Short term effect of withdrawal of diuretic drugs prescribed for ankle oedema. BMJ. 1994;308:511–513
  43. Little P, Williamson I, Warner G, Gould C, Gantley M, Kinmonth AL. Open randomised trial of prescribing strategies in managing sore throat. BMJ. 1997;314:722–727
  44. Thomas KB. General practice consultations (is there any point in being positive?). BMJ. 1987;294:1200
  45. Gryll SL, Katahn M. Situational factors contributing to the placebo effect. Psychopharmacology. 1978;47:253–261
  46. Skovlund E. Should we tell trial patients that they might receive placebos?. Lancet. 1991;337:1041
  47. Knottnerus JA, Dinant GJ. Medicine based evidence, a prerequisite for evidence based medicine. BMJ. 1997;315:309–310

PII: S0895-4356(99)00139-0

Journal of Clinical Epidemiology
Volume 53, Issue 2 , Pages 157-161 , February 2000