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The Placebo Effect and the Pharmaceutical Industry

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Abstract

The placebo effect has long been recognised in medical practice and numerous definitions of the placebo effect and its cause have been proposed. While having a significant impact on study design, it can also be of such a magnitude that pivotal trials demonstrating the superiority of a drug over placebo are difficult to achieve.

This review discusses the factors contributing to the placebo response and why it is such an important consideration for the pharmaceutical industry when designing drug studies. The ethical use of placebos will also be considered, with particular reference to the Declaration of Helsinki and the rights of an individual against the rights of a study population as a whole.

Keywords

Placebo Irritable Bowel Syndrome Sertraline Placebo Effect Placebo Response 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

Notes

Acknowledgements

Both authors are current employees of Pfizer Ltd.

References

  1. 1.
    The humble humbug. Lancet 1954; ii: 321.1Google Scholar
  2. 2.
    Beecher H. The powerful placebo. JAMA 1955; 159: 1602–6CrossRefGoogle Scholar
  3. 3.
    Brody H. Placebos and the philosophy of medicine: clinical, conceptual and ethical issues. Chicago (IL): University of Chicago Press, 1980Google Scholar
  4. 4.
    Shapiro AK. Factors contributing to the placebo effect: their implications for psychotherapy. Am J Psychother 1964; 18: 73–8PubMedGoogle Scholar
  5. 5.
    Gøtzsche PC. Is there logic in the placebo? Lancet 1994; 344: 925–6PubMedCrossRefGoogle Scholar
  6. 6.
    Ernst E, Resch KL. Concept of true and perceived placebo effects. BMJ 1995; 311: 551–3PubMedCrossRefGoogle Scholar
  7. 7.
    Evans D. Placebo: the belief effect. London: Harper Collins, 2003Google Scholar
  8. 8.
    Thompson WG. Placebos: a review of the placebo response. Am J Gastroenterol 2000; 95 (7): 1638–43CrossRefGoogle Scholar
  9. 9.
    Buckalew LW, Coffield KE. An investigation of drug expectancy as a function of capsule colour and size and preparation form. J Clin Psychopharmacol 1982; 2 (4): 245–8PubMedCrossRefGoogle Scholar
  10. 10.
    de Craen AJM, Kaptchuk TJ, Tijssen JGP, et al. Placebo’s and placebo effects in medicine: historical overview. J R Soc Med 1999; 92: 511–5PubMedGoogle Scholar
  11. 11.
    Walsh BT, Seidman SN, Sysko R, et al. Placebo response in studies of major depression: variable, substantial, and growing. JAMA 2002; 287 (14): 1840–7PubMedCrossRefGoogle Scholar
  12. 12.
    Miller CA, Hooper CL, Bakish D. A comparison of placebo response with major depressive disorder in patients. J Psychopharmacol Bull 1997; 33 (4): 647–51Google Scholar
  13. 13.
    Stolk P, Berg MJ, Hemels MEH, et al. Meta-analysis of placebo rates in major depressive disorder trials. Ann Pharmacother 2003; 37: 1891–9PubMedCrossRefGoogle Scholar
  14. 14.
    Fava M, Evins AE, Dorer DJ, et al. The problem of the placebo response in clinical trials for psychiatric disorders: culprits, possible remedies, and a novel study design approach. Psychother Psychosom 2003; 72: 115–27PubMedCrossRefGoogle Scholar
  15. 15.
    Demitrack MA, Faries D, Herrera JM, et al. The problem of measurement error in multisite clinical trials. Psychopharmacol Bull 1998; 34: 19–24PubMedGoogle Scholar
  16. 16.
    Yalcin I, Bump RC. The effect of previous treatment experience and incontinence severity on the placebo response of stress urinary incontinence. Am J Obstet Gynecol 2004; 191: 194–7PubMedCrossRefGoogle Scholar
  17. 17.
    Robinson DS, Rickels D. Concerns about clinical drug trials. J Clin Psychopharmacol 2000; 20: 593–6PubMedCrossRefGoogle Scholar
  18. 18.
    Kobak KA, Greist JH, Jefferson JW, et al. New technologies to improve clinical trials. J Clin Psychopharmacol 2001; 21 (3): 255–6PubMedCrossRefGoogle Scholar
  19. 19.
    World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects [online]. Available from URL: http://www.wma.net/e/policy/b3.htm [Accessed 2005 Oct 14]Google Scholar
  20. 20.
    Temple R, Ellenberg S. Placebo-controlled trials and active-control trials in the evaluation of new treatments: part 1. Ethical and scientific issues. Ann Intern Med 2000; 133: 455–63PubMedGoogle Scholar
  21. 21.
    Tramer M, Reynolds DJM, Moore RA, et al. When placebo controlled trials are essential and equivalence trials are inadequate. BMJ 1998; 317: 875–80PubMedCrossRefGoogle Scholar
  22. 22.
    Hypericum Depression Trial Study Group. Effect of hypericum perforatum (St. John’s Wort) in major depressive disorder: a randomized controlled trial. JAMA 2002; 287: 1807–14CrossRefGoogle Scholar
  23. 23.
    Committee for Proprietary Medicinal Products. Note for guidance on the clinical investigation of medicinal products for the treatment of urinary incontinence [online]. Available from URL: http://www.emea.eu.int/pdfs/human/ewp/001801en.pdfcessed 2005 Oct 14]Google Scholar
  24. 24.
    Emanuel EJ, Miller FG. The ethics of placebo-controlled trials: a middle ground. N Engl J Med 2001; 345: 915–9PubMedCrossRefGoogle Scholar
  25. 25.
    Rothman KJ, Michels KB, Baum M. For and against: Declaration of Helsinki should be strengthened. BMJ 2000; 321: 442–5PubMedCrossRefGoogle Scholar
  26. 26.
    Orentlicher D. Placebo controlled trials of new drugs: ethical considerations. Diabetes Care 2001; 24: 771–2PubMedCrossRefGoogle Scholar

Copyright information

© Adis Data Information BV 2005

Authors and Affiliations

  1. 1.Pfizer LtdSandwich LaboratoriesSandwich, KentEngland

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