Placebo-controlled trials and the Declaration of Helsinki

Lancet. 2002 Apr 13;359(9314):1337-40. doi: 10.1016/S0140-6736(02)08277-6.


A revised version of the Declaration of Helsinki, issued in October, 2000, remains a vital expression of medical ethics, and deserves unanimous support. A strict interpretation of the declaration seems to rule out clinical trials that use a placebo control group whenever licensed therapeutic methods already exist, preferring active controls. Although the efficacy of some new medicines can be satisfactorily established without the use of a placebo, for others the judicious use of placebo remains essential to establish their effectiveness.

MeSH terms

  • Clinical Trials as Topic / methods*
  • Ethics, Medical*
  • Helsinki Declaration*
  • Humans
  • Placebos*


  • Placebos