title: Placebo-controlled trials and the Declaration of Helsinki.
abstract: 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.
authors.affiliation: Hatch Green Cottage, Chartham Hatch, Canterbury, Kent CT4 7LP, UK. john.lewis@clintrial.co.uk
authors.forename: John A
authors.initials: JA
authors.lastname: Lewis
authors.forename: Bertil
authors.initials: B
authors.lastname: Jonsson
authors.forename: Gottfried
authors.initials: G
authors.lastname: Kreutz
authors.forename: Cristina
authors.initials: C
authors.lastname: Sampaio
authors.forename: Barbara
authors.initials: B
authors.lastname: van Zwieten-Boot
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods*; D004992:Ethics, Medical; D006381:Helsinki Declaration; D006801:Humans; D010919:Placebos
chemical_list: D010919:Placebos