The use of a placebo arm remains a highly controversial issue from an ethical point of view and has been addressed in the Declaration of Helsinki. It states that the patients in a study should "be assured of the best proven diagnostic and therapeutic method," even in the control group (2). This clearly implies that a placebo should not be used as a control when superior existing treatment is available. It can be argued that existing studies of combination therapy in acute mania, several published treatment guidelines, and the widespread accepted use of combination treatment among our colleagues support the opinion that a mood stabilizer with an antipsychotic is the best treatment available to date. We, therefore, suggest that it might have been more relevant to omit the placebo group and compare the efficacy of a mood stabilizer in combination with a variety of different antipsychotics. After all, as Hill pointed out in 1963 (3), the key point is how a new treatment compares with existing treatment rather than whether it is better than nothing.