A controlled clinical trial using placebos in normal subjects: a teaching exercise

Abstract

An exercise for medical students was designed to illustrate one method of setting up a clinical trial and incidentally to demonstrate some effects of placebos. Twelve groups of four students participated: one in each group was the "recorder", the other three (volunteers) were randomly assigned to the treatment A, treatment B, or untreated groups. Subjects performed seven psychomotor or mental tests before taking medication and 30 and 60 minutes after medication. The time taken for the tests and the errors made were recorded. Treatment A was one green and yellow gelatin capsule filled with lactose, taken with water; treatment B was a red and white capsule containing lactose; untreated subjects received a drink of water. No large changes in performance occurred and no evidence of fatigue or learning was noted, although the B's took significantly longer to perform the arithmetic test after medication than before. Treated subjects were instructed to check any of 29 listed side effects that they experienced. A total of 44 side effects was reported: 8 of 12 in A group and 10 of 12 in B checked one or more symptoms. Indications are that the results of the trial will not soon be forgotten.