Studies on the Subjective Symptoms of Volunteers Treated with Placebo in Clinical Trials in the Last 13 Years

概要

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Regarding clinical trials, placebo-controlled studies have been widely performed in healthy volunteers to ensure the absolute accuracy of the effect of drugs. However, the occurrence and type of subjective symptoms which are necessary for the evaluation of drug effect, have not been reported in detail. We studied the appearance of subjective symptoms in healthy male volunteers treated with placebo in clinical trials undertaken in the last 13 years at Bio-Iatoric Center of the Kitasato Institute.<BR>The frequency of placebo-induced subjective symptoms was 24.2% (231 out of 954 volunteers). The symptoms with high rates of appearance were headache, abdominal pain and flu-like symptoms. The period during a day when these symptoms were more likely to appear were varied; headache was afternoon, abdominal pain was during the hours following a meal and flu-like symptoms were almost all day long.<BR>A more accurate evaluation of the safety of drugs could be performed for clinical trials, if the results of this study are taken into consideration.