Guest guest Posted September 18, 2003 Report Share Posted September 18, 2003 Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. Hrobjartsson A, Gotzsche PC. Department of Medical Philosophy and Clinical Theory, University of Copenhagen, Panum Institute, and the Nordic Cochrane Centre, Rigshospitalet, Denmark. a.hrobjartsson@... 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 (pooled relative risk of an unwanted outcome with placebo, 0.95; 95 percent confidence interval, 0.88 to 1.02), regardless of whether these outcomes were subjective or objective. For the trials with continuous outcomes, placebo had a beneficial effect (pooled standardized mean difference in the value for an unwanted outcome between the placebo and untreated groups, -0.28; 95 percent confidence interval, -0.38 to -0.19), 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 (-0.36; 95 percent confidence interval, -0.47 to -0.25) but not for those with objective outcomes. In 27 trials involving the treatment of pain, placebo had a beneficial effect (-0.27; 95 percent confidence interval, -0.40 to -0.15). This corresponded to 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. ----------------------------------- This is an abstract of the article cited in quackwatch. I know these people mean well, but spare me! For about 8 *years* I said " but there really is something wrong with me. I have numbness in two fingers that never goes away. Occasionally I limp for no reason. I have been seeing double. " I was dismissed as a hypochondriac. Those people would have had a lot less to put up with had I been correctly diagnosed. Now I am hearing that folks who have had a prolonged remission from progressive MS are just imagining things. In your dreams! If somebody tells you they're sick, they probably are, even if *you* can't diagnose it. If somebody with progressive MS tells you they're feeling better, you had better listen! It is a violation of the Hippocratic oath to deliberately ignore a valid treatment, just as surely as it is to administer poison. It is a sin of omission that can cause great harm. Use of placebo outside of the conditions stated in the conclusions above is misleading to the scientific and general public, where objective measures are available (MRI, EDSS, etc.). It leads them not to believe empirical evidence unless it is compared statistically to placebo. If most people could cure MS by mental force they would. If someone tells you they are in remission for the first time in years, look for a reason and don't tell them they did it by pseudo-magic jiggery pokery. Measure it! The other thing about the placebo effect is it does not last. It cannot last for a year. So what's the use of controlling with it in a two year trial? Forget it, man, it can't happen. Unless you happen to *like* making people poke themselves with needles and inject saline. So don't bother calculating statistical validity as compared to placebo when it is exactly the same (except for sadistic thrills) as no treatment. -Sullivan " He's not pining, he's passed on... this is an ex-parrot! " Quote Link to comment Share on other sites More sharing options...
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