A comparison of symptom provocation procedures in psychiatry and other areas of medicine: implications for their ethical use in research

Background: Symptom provocation is used to study a wide variety of medical disorders. In contrast to other areas of medicine, the application of these procedures to the study of mental disease has generated significant scientific, political, and public debate. Purported differences include an overabundance of these procedures in psychiatry and a lack of diagnostic and therapeutic utility. Accurate appraisal of these research designs is needed to address scientific merit and ethical concerns. This article provides a general review of challenge studies in several areas of medical research, compares purposes and methods to those used in psychiatry, and ascertains whether fundamental differences exist. Methods: In total, 655 challenge studies were identified using MEDLINE and PsychInfo Boolean key word searches. Information was collected from each study including the year of publication, whether subjects were healthy or patient volunteers, the disease being studied, and the study purpose (e.g., to study pathophysiology, test treatment efficacy, or diagnosis of a disorder). Results: Differences in study design, purpose, and frequency of studies across time were similar for medical and psychiatric diseases. Conclusions: Given extensive similarity in purpose and procedures, why are psychiatric challenge studies being subjected to public criticism and special review and approval procedures? Several relevant issues are addressed including risk, scientific merit, and clinical application.