The leading ethical position on placebo-controlled clinical trials is that whenever proven effective treatment exists for a given condition, it is unethical to test a new treatment for that condition against placebo. Invoking the principle of clinical equipoise, opponents of placebo-controlled trials in the face of proven effective treatment argue that they (1) violate the therapeutic obligation of physicians to offer optimal medical care and (2) lack both scientific and clinical merit. We contend that both of these arguments are mistaken. Clinical equipoise provides erroneous ethical guidance in the case of placebo-controlled trials, because it ignores the ethically relevant distinction between clinical trials and treatment in the context of clinical medicine and the methodological limitations of active-controlled trials. Placebo controls are ethically justifiable when they are supported by sound methodological considerations and their use does not expose research participants to excessive risks of harm.
The purposes of this paper are to review: (a) selected aspects of the history and prevalence of anabolic-androgenic steroid use in competitive sports; (b) some effects of androgens on the central and peripheral nervous system; (c) the relationship between endogenous plasma testosterone levels and mood and behaviour in normal males and in prisoner populations; (d) the effects of the clinical use of anabolic-androgenic steroids on mood and behaviour in hypogonadal males and depressed patients; (e) the relationship of anabolic-androgenic steroid use to aggression and mental health in athletes, including issues of psychological dependence and withdrawal; and (f) the major relationship between anabolic-androgenic steroid administration, mood and behaviour.