The role of compassion in the practice of evidence-based medicine

Patients with diseases having a high failure rate with standard treatments typically enroll in randomized clinical trials of new investigational treatments. Not all potential therapies are amenable to these types of designs and thus may be offered compassionately; however, claims of efficacy are thus viewed with caution. In a paper in this issue, 43 patients with recurrent Clostridium difficile infections were treated with fecal microbiota transplants using a compassionate use protocol. By using standardized healthy donor stool preparations and following standardized protocols, the 92% response rate can be viewed with more confidence than other case series reports.