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The New England Journal of Medicine Volume 344:1594-1602 May 24, 2001 Number 21 Is the Placebo Powerless? - An Analysis of Clinical Trials Comparing Placebo with No Treatment Asbjorn Hrobjartsson, M.D., and Peter C. Gotzsche, M.D. ABSTRACT Background Placebo treatments have been reported to help patients with many diseases, but the quality of the evidence supporting this finding has not been rigorously evaluated. Methods We conducted a systematic review of clinical trials in which patients were randomly assigned to either placebo or no treatment. A placebo could be pharmacologic (e.g., a tablet), physical (e.g., a manipulation), or psychological (e.g., a conversation). Results We identified 130 trials that met our inclusion criteria. After the exclusion of 16 trials without relevant data on outcomes, there were 32 with binary outcomes (involving 3795 patients, with a median of 51 patients per trial) and 82 with continuous outcomes (involving 4730 patients, with a median of 27 patients per trial). As compared with no treatment, placebo had no significant effect on binary outcomes, regardless of whether these outcomes were subjective or objective. For the trials with continuous outcomes, placebo had a beneficial effect, but the effect decreased with increasing sample size, indicating a possible bias related to the effects of small trials. The pooled standardized mean difference was significant for the trials with subjective outcomes but not for those with objective outcomes. In 27 trials involving the treatment of pain, placebo had a beneficial effect, as indicated by a reduction in the intensity of pain of 6.5 mm on a 100-mm visual-analogue scale. Conclusions We found little evidence in general that placebos had powerful clinical effects. Although placebos had no significant effects on objective or binary outcomes, they had possible small benefits in studies with continuous subjective outcomes and for the treatment of pain. Outside the setting of clinical trials, there is no justification for the use of placebos. Source Information From the Department of Medical Philosophy and Clinical Theory, University of Copenhagen, Panum Institute, and the Nordic Cochrane Centre, Rigshospitalet — both in Copenhagen, Denmark. Address reprint requests to Dr. Hróbjartsson at the Department of Medical Philosophy and Clinical Theory, University of Copenhagen, Panum Institute, Blegdamsvej 3, DK-2200 Copenhagen N, Denmark, or at [log in to unmask] Sign in for Full Text This article has been cited by other articles: Bailar, J. C. III. (2001). The Powerful Placebo and the Wizard of Oz. N Engl J Med 344: 1630-1632 [Full Text] (Full text articles are only available online to paid subscribers) SOURCE: The New England Journal of Medicine http://content.nejm.org/cgi/content/abstract/344/21/1594 * * * [log in to unmask] ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn