Wednesday, January 16, 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 an RCT that demonstrates the clinical utility of fecal transplantation for C. 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 $1500.

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?

Graphic:  Andrea Levy, Cleveland Plain Dealer.

2 comments:

  1. I'm waiting for the meta-analysis. Mostly joking, but still this is one study. I suspect efficacy is proven or will be after 1-2 more trials. Effectiveness will take a bit more time. Will be really great when standard microbiota become available for infusion, without the need for expensive testing.

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