Science and Engineering Ethics

, Volume 10, Issue 1, pp 151–155 | Cite as

Placebo treatment is effective differently in different diseases — but is it also harmless? A brief synopsis

Article

Abstract

The placebo drug reactions from controlled trials were studied for the first time systematically for efficacy and the safety in drug data pooled from randomized, placebo-controlled, multicentre studies. Results: The efficacy of placebo on clinical symptoms and outcome varied between the therapeutic indications. However, no placebo effects on laboratory values, as e.g. blood glucose or Hb1c in diabetics, were noted. The frequency and type of placebo-induced adverse reactions also varied between indication groups. The placebo side effect profile was largely similar to the side effect profile of the active treatment. The mechanisms of placebo effects are manyfold and varied (e.g. endorphin release, conditioning), much lacks explanation. Conclusion: Since the prescription of non-evidence based medicines (= pseudoplacebos) may clearly also result in serious adverse effects, such practice may not only be non-beneficial but may even be harmful. In clinical research, the judicious use of placebo remains essential to establish the efficacy and safety, safeguarding that patients receiving placebo will not be subject to harm and are fully informed.

Keywords

placebo efficacy adverse drug reactions clinical trials ethics Declaration of Helsinki 

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References

  1. 1.
    Weihrauch TR and Gauler TC (1999): Placebo — Efficacy and adverse effects in controlled clinical trials, Drug Res. 49 (I), 5: 385–93.Google Scholar
  2. 2.
    World Medical Association of Helsinki(as revised Edinburgh 2000), www.wma./net/policy.Google Scholar
  3. 3.
    Lewis JA et al. (2002) Placebo controlled trials and the Declaration of Helsinki, Lancet 359: 1337–40.CrossRefGoogle Scholar
  4. 4.
    Temple R, Ellenberg SS (2000) Placebo-controlled trials and active-controlled trials in the evaluation of new treatments, part1: ethical and scientific issues, Ann Intern Med 133: 455–62.Google Scholar
  5. 5.
    Pigeot I, Schäfer J, Röhmel J, Hauschke D (2003) Assessing non-inferiority of a new treatment in a three-arm clinical trial including a placebo: Stat. Med. 22: 883–899.CrossRefGoogle Scholar
  6. 6.
    EMEA/CPMP Position statement on the use of placebo in clinical trials with regard to the revised Declaration of Helsinki. www.emea.eu.int/index/indexhl.htm (28 June 2001).Google Scholar
  7. 7.
    Huston P and Petersen R (2001) Withholding proven treatment in clinical research, NEJM (editorial) 345: 912–914.CrossRefGoogle Scholar
  8. 8.
    Anonymous: Choice of control group in clinical trials, ICH E10 (2000).London: EMEA http://www.ich.org/ich7.html.Google Scholar

Copyright information

© Opragen Publications 2003

Authors and Affiliations

  1. 1.FFPM, Pharmaceutical Research Center, Bayer AG, Aprather WegWuppertalGermany

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