© 2002 Evidence-Based Mental Health
Therapeutics
Review: placebo is better than no treatment for subjective continuous outcomes and for treatment of pain
Hróbjartsson A, Gøtzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med 2001 May 24;344:1594602
QUESTIONS: In patients with various clinical conditions, what is the clinical effect of placebo as a treatment for disease? Does the effect differ for subjective and objective outcomes?
Trials published before the end of 1998 were identified by searching Medline, EMBASE/Excerpta Medica, PsycLIT, Biological Abstracts, and the Cochrane Controlled Trials Register. The search terms were synonyms of placebo, no treatment, and randomised clinical trial. Reference lists of included trials and selected review articles and books were reviewed, and experts were contacted.
Studies were selected if patients were randomly allocated to a placebo group or an untreated group. Exclusion criteria were unconcealed randomisation, sample of paid or healthy volunteers, non-blinding of assessors of objective outcomes, >50% dropouts, or if the alleged placebo had a clinical effect not associated with the treatment ritual alone.
Data were extracted using predetermined forms. Primary outcome of interest was the main outcome defined by the trial author or if not defined, the most clinically relevant outcome.
114 trials published from 194698 were included in the analysis. The typical placebo for drugs was a lactose
Nagoya City University Nagoya, Japan
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[Abstract] [Full Text]
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