Blog | Friday, February 22, 2013

Proof


Finally, the purists out there who require demonstration of efficacy by a randomized clinical trial before attempting a novel therapy can now breathe a great sigh of relief. The New England Journal of Medicine has just published a randomized, controlled trial that demonstrates the clinical utility of fecal transplantation for Clostridium difficile infection. In fact, fecal transplants worked so well that the trial was terminated early after an interim analysis.

Patients in the study all had C. difficile infection with at least one relapse. They were randomized to one of three study arms: (1) a 4-day course of oral vancomycin followed by bowel lavage then fecal transplant via nasoduodenal tube; (2) a 14-day course of oral vancomycin; or (3) oral vancomycin plus bowel lavage. In the transplant group, 13 of 16 patients were cured after 1 fecal infusion (2 of the remaining 3 were cured after a second infusion). In contrast only 4 of 13 in the vanco group, and 3 of 13 in the vanco plus lavage group were cured. Bottom line: fecal transplantation had an overall cure rate of 96%.

There remain two barriers for patients to access this highly effective therapy: (1) very few physicians perform the procedure, in part, I think, because there is no reimbursement despite the several person-hours required to prepare the fecal solution and administer it; and (2) insurance companies will not reimburse for donor testing, which costs approximately $1,500.

So we've proven what we already knew. Now it's time to look at more interesting questions: Does fecal transplantation work for irritable bowel syndrome and inflammatory bowel disease?

Michael B. Edmond, MD, FACP, is a hospital epidemiologist in Richmond, Va., with a focus on understanding why infections occur in the hospital and ways to prevent these infections, and sees patients in the inpatient and outpatient settings. This post originally appeared at the blog Controversies in Hospital Infection Prevention.