C. difficile patients embrace therapy, despite 'ick factor'
A micrograph image of C. difficile bacteria is shown in a handout photo. (The U.S. Centers for Disease Control and Prevention)
Published Friday, September 21, 2012 7:14AM EDT
Last Updated Friday, September 21, 2012 10:21AM EDT
TORONTO -- The grossness notwithstanding, people would likely agree to undergo a fecal transplant if they were suffering from persistent C. difficile diarrhea, a new study suggests.
The study found that though people felt the whole process was highly off-putting, most would opt for the procedure if they needed it, especially if it was recommended by their doctor.
While the study is small, it suggests the rationale behind some doctors's refusal to perform fecal transplants -- they say patients wouldn't undergo the procedure -- is unfounded, says the lead author, Dr. Jonathan Zipursky.
"That was initially what the theory was in the literature, that patients wouldn't be willing to accept this because of the yuck factor," says Zipursky, a first-year resident in internal medicine at the University of Toronto.
"But I think we've shown pretty strongly that under the correct circumstances and with the right counselling and recommendations that patients definitely are willing to try this treatment for recurrent Clostridium difficile infection."
The study, which Zipursky did with fellow students while in medical school at Dartmouth College in Hanover, N.H., was published this week in the journal Clinical Infectious Diseases.
The procedures -- also known by the name fecal microbiota transplantation -- were first reported in the medical literature in the 1950s. But they have only started to take hold in recent years as a option for people suffering from persistent C. difficile diarrhea.
The idea behind the therapy is to restore the bacterial balance in the C. diff sufferer's gastrointestinal tract using bacteria from a healthy gut. That comes in the form of feces from a healthy person.
The donor stool, which is diluted with saline to form a slurry, can be introduced into the gastric system by one of three ways. It can be dripped into the stomach by a tube snaked through a nostril and down the esophagus. It can be deposited into the lower bowel in a sort of reverse enema procedure. Or it can be pumped into the intestine using a scope such as the type used in colonoscopies.
The evidence to date suggests the procedure is highly effective. Upwards of 90 per cent of people suffering from C. difficile diarrhea are reportedly cured after fecal transplants. In many cases, a single time suffices.
But that estimate is based on case studies -- reports from doctors who do the procedure on how it worked in a series of their patients. While the findings are persuasive, this kind of study is not the gold standard of evidence. That title is held by what is called a randomized controlled trial.
And so far there are no published randomized controlled trials of fecal transplants, though results of a European trial are expected soon. As well, U.S. health authorities recently approved a randomized clinical trial there.
Dr. Lawrence Brandt, of Montefiore Medical Center in Bronx, N.Y., is co-head of that trial. Brandt has done more than 100 fecal transplants. He suggests in a commentary published with Zipursky's study that these findings lob the ball back in to court of reluctant doctors.
Brandt says many of the patients he has treated seek him out in their desperation for a fecal transplant. They're looking for a cure for a condition that's far worse than the therapy itself, he says.
"What had been the major stumbling block for many was the intransient negativism of their physicians who told them, uninfluenced by any of the positive reported data, that FMT was 'quackery,' 'a joke,' 'snake oil' or other pithy alliterations that were discouraging and served to delay but not persuade these perseverant individuals," Brandt writes.
A group in Toronto is also trying to conduct a clinical trial, but has had trouble enrolling enough patients. The problem? People who have recurrent C. difficile and who hear about the trial want the treatment. They don't want to run the risk they will be randomly assigned to get the therapy fecal transplants are being compared to -- another course of the antibiotics that have thus far failed to cure them.
What's interesting about the study Zipursky and his co-authors conducted is that it didn't measure the acceptability of fecal transplants among C. difficile patients. Instead, they surveyed people who had no experience with the condition, people who haven't known the desperation that comes with recurrent C. diff.
In the first part of their questionnaire, respondents were presented with a scenario. They had C. difficile. Would they accept treatment with antibiotics (with a 65 per cent chance of cure) or antibiotics followed by a treatment called "floral reconstitution" (with a 90 per cent cure rate)? There were no details about what floral reconstruction was.
Then respondents were presented with a second scenario, identical to the first but with a description of what floral reconstitution is and what it entails.
After reading the scenario 1, 85 per cent of the respondents said they'd agree to have floral reconstitution. After reading scenario 2, 81 per cent still said they would have the procedure. The difference wasn't statistically significant.
Most described the steps of the procedure as "unappealing" or "gross", in the words of the survey. But not only did most say they would have the procedure if they needed it, 77 per cent said they would pay out of pocket for it.
Dr. Vivian Loo, a C. difficile expert from Montreal, notes the study was small. Only 192 participants completed the survey, 48 per cent of the total who were asked. The people who didn't complete the survey might have felt differently about the questions, so the participation rate could have skewed the findings, she warns.
Still, Loo believes that fecal transplants are a promising option, one that will be embraced with more frequency, and soon.
"There is a certain expertise (needed) in its administration, but I think it will become more widely acceptable as we gain more experience with it," says Loo, who is chief of microbiology for the Montreal University Health Centre.
Loo doesn't do fecal transplants herself, because of time constraints. But she refers patients who want them to a colleague in Montreal who does them.
"There aren't many treatments that promise a 95 per cent cure rate. And the evidence that is there does seem to suggest it has a very high success rate."
Brandt too says he feels a shift in attitudes coming.
Zipursky and co-authors are in the process of analyzing data from a companion study they are doing, based on surveys on fecal transplants completed by U.S. doctors.
Comparing the patient and the doctor data will be interesting, he says. But he adds it may take strong evidence from randomized controlled trials to persuade reluctant doctors to incorporate fecal transplants in their arsenal for C. difficile.